DiabetesPhase 3NCT00700817
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing liraglutide, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 166 sites in 15 countries.
Trial summary
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide, sitagliptin and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 665 participants
- Where
- 166 sitesin 15 countries
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Treatment with metformin alone for at least three months
- HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
- Body Mass Index (BMI) less than or equal to 45.0
Who cannot join
- Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
- Treatment with anti-diabetic drugs other than metformin within the last three months
- Any serious medical condition
- Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Trial locations and contacts
166 sites in 15 countries.
166 sites in 15 countries
United States60 sites
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Birmingham, Alabama, 35242
Novo Nordisk Investigational Site
Boise, Idaho, 83702
Novo Nordisk Investigational Site
Chicago, Illinois, 60616
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
Novo Nordisk Investigational Site
Cleveland, Mississippi, 38732
Novo Nordisk Investigational Site
Columbus, Ohio, 43201
Novo Nordisk Investigational Site
Crystal River, Florida, 34429
Novo Nordisk Investigational Site
Cuyahoga Falls, Ohio, 44223
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Denver, Colorado, 80209
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Eugene, Oregon, 97404
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89109
Novo Nordisk Investigational Site
Lithia Springs, Georgia, 30122
Novo Nordisk Investigational Site
Long Beach, California, 90822
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Metairie, Louisiana, 70002
Novo Nordisk Investigational Site
Miami, Florida, 33169
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
New Braunfels, Texas, 78130
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Ogden, Utah, 84403
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Panama City, Florida, 32401
Novo Nordisk Investigational Site
Pinehurst, North Carolina, 28374
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
Rosedale, New York, 11422
Novo Nordisk Investigational Site
Saint Cloud, Florida, 34769
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, 66204
Novo Nordisk Investigational Site
South Burlington, Vermont, 05403
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tabor City, North Carolina, 28463
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
United Kingdom20 sites
Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Abergavenny, NP7 7EG
Novo Nordisk Investigational Site
Aldershot, GU12 5BA
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Chippenham, SN15 2SB
Novo Nordisk Investigational Site
Coventry, CV6 2FL
Novo Nordisk Investigational Site
Edgbaston, Birmingham, B15 2TH
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
Novo Nordisk Investigational Site
Glasgow, G45 9AW
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
Letchworth Garden City, SG6 4UB
Novo Nordisk Investigational Site
Liverpool, L9 7AL
Novo Nordisk Investigational Site
Maidstone, ME16 9QQ
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Oxford, OX3 7LE
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Germany12 sites
Novo Nordisk Investigational Site
Bad Lauterberg im Harz, 37431
Novo Nordisk Investigational Site
Bochum, 44791
Novo Nordisk Investigational Site
Dormagen, 41539
Novo Nordisk Investigational Site
Frankfurt, 60388
Novo Nordisk Investigational Site
Herrenberg, 71083
Novo Nordisk Investigational Site
Kassel, 34117
Novo Nordisk Investigational Site
Marburg, 35039
Novo Nordisk Investigational Site
Riesa, 01587
Novo Nordisk Investigational Site
Schönebeck, 39218
Novo Nordisk Investigational Site
Ulm, 89073
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Wangen, 88239
Canada11 sites
Novo Nordisk Investigational Site
Edmonton, Alberta, T5A 4L8
Novo Nordisk Investigational Site
Hamilton, L8M 1K7
Novo Nordisk Investigational Site
London, Ontario, N6G 2M1
Novo Nordisk Investigational Site
Montreal, Quebec, H2W 1T8
Novo Nordisk Investigational Site
Montreal, Quebec, H3J 2V5
Novo Nordisk Investigational Site
Newmarket, Ontario, L4Y 8E3
Novo Nordisk Investigational Site
Ottawa, Ontario, K1N 6N5
Novo Nordisk Investigational Site
Toronto, Ontario, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, M5C 2T2
Novo Nordisk Investigational Site
Toronto, Ontario, M5T 3L9
Novo Nordisk Investigational Site
Vancouver, British Columbia, V5Z 1M9
Netherlands10 sites
Novo Nordisk Investigational Site
Almere Stad, 1311RL
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Beek, 6191JW
Novo Nordisk Investigational Site
Groningen, 9728 NT
Novo Nordisk Investigational Site
Hengelo, 7555 DL
Novo Nordisk Investigational Site
Leiden, 2333 ZA
Novo Nordisk Investigational Site
Roelofarendsveen, 2371 RB
Novo Nordisk Investigational Site
Stadskanaal, 9501 EH
Novo Nordisk Investigational Site
Zevenaar, 6903 ZN
Novo Nordisk Investigational Site
Zoetermeer, 2725 NA
Italy9 sites
Novo Nordisk Investigational Site
Catania, 95124
Novo Nordisk Investigational Site
Lucca, 55100
Novo Nordisk Investigational Site
Messina, 98123
Novo Nordisk Investigational Site
Olbia, 07026
Novo Nordisk Investigational Site
Palermo, 90123
Novo Nordisk Investigational Site
Pavia, 27100
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Siena, 53100
Novo Nordisk Investigational Site
Trieste, 34148
Spain9 sites
Novo Nordisk Investigational Site
Alzira, 46600
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Getafe, 28905
Novo Nordisk Investigational Site
L'Hospitalet de Llobregat, 08907
Novo Nordisk Investigational Site
Málaga, 29010
Novo Nordisk Investigational Site
Oviedo, 33006
Novo Nordisk Investigational Site
Palma de Mallorca, 07010
Novo Nordisk Investigational Site
Palma de Mallorca, 07014
Novo Nordisk Investigational Site
Puerto del Rosario, 35600
France8 sites
Novo Nordisk Investigational Site
La Roche-sur-Yon, 85295
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Limoges, 87042
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Saint-Mandé, 94160
Novo Nordisk Investigational Site
Strasbourg, 67000
Novo Nordisk Investigational Site
Vénissieux, 69200
Ireland5 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, DUBLIN 4
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
Puerto Rico5 sites
Novo Nordisk Investigational Site
Caquas, 00725
Novo Nordisk Investigational Site
Guaynabo, 00968
Novo Nordisk Investigational Site
Manati, 00674
Novo Nordisk Investigational Site
Rio Piedras, 00921
Novo Nordisk Investigational Site
Trujillo Alto, 00976
Slovakia5 sites
Novo Nordisk Investigational Site
Bratislava, 811 08
Novo Nordisk Investigational Site
Bratislava, 82102
Novo Nordisk Investigational Site
Bratislava, 851 05
Novo Nordisk Investigational Site
Nitra, 94 911
Novo Nordisk Investigational Site
Nové Zámky, 940 59
Romania4 sites
Novo Nordisk Investigational Site
Bucharest, 020614
Novo Nordisk Investigational Site
Craiova, Dolj, 200642
Novo Nordisk Investigational Site
Oradea, Bihor County, 410469
Novo Nordisk Investigational Site
Timișoara, 300736
Croatia3 sites
Novo Nordisk Investigational Site
Karlovac, 47000
Novo Nordisk Investigational Site
Sisak, 44000
Novo Nordisk Investigational Site
Slavonski Brod, 35 000
Slovenia3 sites
Novo Nordisk Investigational Site
Ljubljana, 1525
Novo Nordisk Investigational Site
Novo Mesto, 8000
Novo Nordisk Investigational Site
Trbovlje, 1420
Serbia and Montenegro2 sites
Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Nis, 18000
About this study
Official title: The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.
The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
Read more
- Week 27-52 after randomisation
- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
- Week 53-78 after randomisation
- Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
- Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, sitagliptin, metformin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
1.2 mg once daily, subcutaneous (under the skin) injection
sitagliptinDrug
Tablets, 100 mg daily
metforminDrug
Tablets, minimum 1500 mg daily
liraglutideDrug
1.8 mg once daily, subcutaneous (under the skin) injection
| Study group | Role | What they receive |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Experimental | Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Receives: Drug: liraglutide; Drug: metformin |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Experimental | Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Receives: Drug: metformin; Drug: liraglutide |
| Sita -> Sita | Active comparator | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Receives: Drug: sitagliptin; Drug: metformin |
| Sita -> Sita -> Lira 1.2 mg | Experimental | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Receives: Drug: liraglutide; Drug: sitagliptin; Drug: metformin |
| Sita -> Sita -> Lira 1.8 mg | Experimental | Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. Receives: Drug: sitagliptin; Drug: metformin; Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Measured: Week 0, Week 52
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Measured: Week 0, Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Measured: Week 52, Week 78
Secondary outcomes (71)
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Measured: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52
Measured: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.
Measured: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.
Measured: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26
Measured: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52
Measured: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.
Measured: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.
Measured: Week 0, Week 78
Mean Change From Baseline in Body Weight at Week 26
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Body Weight at Week 52
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Measured: Week 0, Week 52
Mean Change in Body Weight From Week 52 to Week 78
Mean change in body weight from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Measured: Week 0, Week 52
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Measured: Week 0, Week 78
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Beta-cell Function at Week 26
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.
Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Measured: Week 0, Week 26
Mean Change From Baseline in Beta-cell Function at Week 52
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.
Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Measured: Week 0, Week 52
Mean Change in Beta-cell Function From Week 52 to Week 78
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Measured: Week 52, Week 78
Mean Change From Baseline in Total Cholesterol at Week 26
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Total Cholesterol at Week 52
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Measured: Week 0, Week 52
Mean Change in Total Cholesterol From Week 52 to Week 78
Mean change in total cholesterol from Week 52 to Week 78
Measured: Week 52, Week 78
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Measured: Week 0, Week 52
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Measured: Week 0, Week 52
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Measured: Week 0, Week 52
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Triglycerides (TG) at Week 26
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Triglycerides (TG) at Week 52
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Measured: Week 0, Week 52
Mean Change in Triglycerides (TG) From Week 52 to Week 78
Mean change in triglycerides (TG) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Measured: Week 0, Week 52
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Apolipoprotein B at Week 26
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Apolipoprotein B at Week 52
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Measured: Week 0, Week 52
Mean Change in Apolipoprotein B From Week 52 to Week 78
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Adiponectin at Week 26.
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Measured: Week 0, Week 26
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Measured: Week 0, Week 26
Mean Change From Baseline in Waist to Hip Ratio at Week 52
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Measured: Week 0, Week 52
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Measured: Week 52, Week 78
Mean Change From Baseline in Waist Circumference at Week 26.
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Measured: Week 0, Week 26
Mean Change From Baseline in Waist Circumference at Week 52
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Measured: Week 0, Week 52
Mean Change in Waist Circumference From Week 52 to Week 78
Mean change in Waist Circumference from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Measured: Week 0, Week 26
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Measured: Week 0, Week 52
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Measured: Week 0, Week 52
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Pulse at Week 26
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Measured: Week 0, Week 26
Mean Change From Baseline in Pulse at Week 52
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Measured: Week 0, Week 52
Mean Change in Pulse From Week 52 to Week 78
Mean change in pulse from Week 52 to Week 78.
Measured: Week 52, Week 78
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Measured: Week 0, Week 26
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Measured: Week 0, Week 52
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Measured: Week 52, Week 78
Hypoglyceamic Episodes, Weeks 0-26
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-26
Hypoglyceamic Episodes, Weeks 0-52
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-52
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-52
Hypoglyceamic Episodes, Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-78
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-78
Hypoglycaamic Episodes, Weeks 52-78
Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Week 52-78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700817
- Sponsor's protocol ID
- NN2211-1860
- Other IDs
- 2007-003937-17
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2008
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8.
PubMed 20417856Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.
PubMed 21309842Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.
PubMed 21355967Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
PubMed 22193143Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
PubMed 21883806Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.
PubMed 21883438Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.
PubMed 22851600Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13.
PubMed 22834986Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
PubMed 22862847Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
PubMed 23010561King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
PubMed 23186975Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PubMed 25504028Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.
PubMed 26936426Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237.
PubMed 23537458
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
- ClinicalTrials.gov ID
- NCT00700817
- Acronym / sponsor ID
- NN2211-1860
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 4 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.
The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
- Week 27-52 after randomisation
- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
- Week 53-78 after randomisation
- Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
- Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Experimental | Drug: liraglutide, Drug: metforminOnce-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Experimental | Drug: metformin, Drug: liraglutideOnce-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). |
| Sita -> Sita | Active comparator | Drug: sitagliptin, Drug: metforminOnce-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). |
| Sita -> Sita -> Lira 1.2 mg | Experimental | Drug: liraglutide, Drug: sitagliptin, Drug: metforminOnce-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. |
| Sita -> Sita -> Lira 1.8 mg | Experimental | Drug: sitagliptin, Drug: metformin, Drug: liraglutideOnce-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Treatment with metformin alone for at least three months
- HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
- Body Mass Index (BMI) less than or equal to 45.0
Key exclusion criteria (4 listed)
- Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
- Treatment with anti-diabetic drugs other than metformin within the last three months
- Any serious medical condition
- Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide1.2 mg once daily, subcutaneous (under the skin) injection | Drug | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Sita -> Sita -> Lira 1.2 mg |
| sitagliptinTablets, 100 mg daily | Drug | Sita -> Sita, Sita -> Sita -> Lira 1.2 mg, Sita -> Sita -> Lira 1.8 mg |
| metforminTablets, minimum 1500 mg daily | Drug | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita, Sita -> Sita -> Lira 1.2 mg, Sita -> Sita -> Lira 1.8 mg |
| liraglutide1.8 mg once daily, subcutaneous (under the skin) injection | Drug | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita -> Lira 1.8 mg |
Primary outcome
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Time frame: Week 0, Week 26
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Time frame: Week 0, Week 52
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Time frame: Week 0, Week 78
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
71 secondary outcomes
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Time frame: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Time frame: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Time frame: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Time frame: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time frame: Week 0, Week 78
Mean Change From Baseline in Body Weight at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Body Weight at Week 52
Time frame: Week 0, Week 52
Mean Change in Body Weight From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time frame: Week 0, Week 52
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Time frame: Week 0, Week 78
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Beta-cell Function at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Beta-cell Function at Week 52
Time frame: Week 0, Week 52
Mean Change in Beta-cell Function From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Total Cholesterol at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Total Cholesterol at Week 52
Time frame: Week 0, Week 52
Mean Change in Total Cholesterol From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Time frame: Week 0, Week 52
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Time frame: Week 0, Week 52
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Time frame: Week 0, Week 52
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Triglycerides (TG) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Triglycerides (TG) at Week 52
Time frame: Week 0, Week 52
Mean Change in Triglycerides (TG) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Time frame: Week 0, Week 52
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Apolipoprotein B at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Apolipoprotein B at Week 52
Time frame: Week 0, Week 52
Mean Change in Apolipoprotein B From Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Time frame: Week 0, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20417856Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8.
- Results publication: PubMed 21309842Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.
- Results publication: PubMed 21355967Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.
- Results publication: PubMed 22193143Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
- Results publication: PubMed 21883806Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
- Results publication: PubMed 21883438Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.
- Results publication: PubMed 22851600Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.
- Results publication: PubMed 22834986Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13.
- Results publication: PubMed 22862847Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
- Results publication: PubMed 23010561Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
- Results publication: PubMed 23186975King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
- Results publication: PubMed 25504028Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
166 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 166 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 166 sites in United States, United Kingdom, Germany, Canada, Netherlands and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (time frame: Week 0, Week 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00700817, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.