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AzTrials

DiabetesPhase 3NCT00856986

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

A Phase 3 study testing liraglutide, insulin detemir and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 233 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
liraglutide, insulin detemir and metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
987 participants
Where
233 sitesin 10 countries
Study dates
Mar 2009to Nov 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 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
  • HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
  • HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea

Who cannot join

  • Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
  • Impaired kidney function
  • Impaired liver function
  • Uncontrolled treated/untreated hypertension
Show all 9Show fewer
  • Cancer or any clinically significant disease or disorder as judged by the Investigator
  • Previous participation in the run-in phase of this trial. Re-screening is allowed once
  • History of chronic pancreatitis or idiopathic pancreatitis

Trial locations and contacts

233 sites in 10 countries.

233 sites in 10 countries

United States60 sites

  • Novo Nordisk Investigational Site

    Alexander City, Alabama, 35010

  • Novo Nordisk Investigational Site

    Atlanta, Georgia, 30308-2253

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21204

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35294

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60616

  • Novo Nordisk Investigational Site

    Chicago Heights, Indiana, 60411

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45226

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45245

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33765

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78412

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75235-6233

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Danville, Pennsylvania, 17822

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45439

  • Novo Nordisk Investigational Site

    Decatur, Georgia, 30033

  • Novo Nordisk Investigational Site

    Durham, North Carolina, 27710

  • Novo Nordisk Investigational Site

    Encino, California, 91436

  • Novo Nordisk Investigational Site

    Fullerton, California, 92835

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Inglewood, California, 90301

  • Novo Nordisk Investigational Site

    Jupiter, Florida, 33458-7200

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Los Gatos, California, 95032

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky, 42431

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38119

  • Novo Nordisk Investigational Site

    Methuen, Massachusetts, 01844

  • Novo Nordisk Investigational Site

    Miami, Florida, 33136

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Miami, Florida, 33169

  • Novo Nordisk Investigational Site

    Midland, Texas, 79707

  • Novo Nordisk Investigational Site

    Milwaukee, Wisconsin, 53209

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    New Hyde Park, New York, 11042

  • Novo Nordisk Investigational Site

    Northport, New York, 11768

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73103

  • Novo Nordisk Investigational Site

    Orem, Utah, 84058

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19152

  • Novo Nordisk Investigational Site

    Plano, Texas, 75075

  • Novo Nordisk Investigational Site

    Quincy, Illinois, 62301

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23249

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23294

  • Novo Nordisk Investigational Site

    Rockville, Maryland, 20852

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Savannah, Georgia, 31405

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63104

  • Novo Nordisk Investigational Site

    State College, Pennsylvania, 16801

  • Novo Nordisk Investigational Site

    Syracuse, New York, 13210

  • Novo Nordisk Investigational Site

    The Bronx, New York, 10461-2665

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Waterbury, Connecticut, 06712

  • Novo Nordisk Investigational Site

    Willkes Barre, Pennsylvania, 18702

Other trials in United States

Germany39 sites

  • Novo Nordisk Investigational Site

    Augsburg, 86150

  • Novo Nordisk Investigational Site

    Bad Kreuznach, 55545

  • Novo Nordisk Investigational Site

    Bad Mergentheim, 97980

  • Novo Nordisk Investigational Site

    Bad Nauheim, 61231

  • Novo Nordisk Investigational Site

    Berlin, 10789

  • Novo Nordisk Investigational Site

    Berlin, 12163

  • Novo Nordisk Investigational Site

    Berlin, 13055

  • Novo Nordisk Investigational Site

    Bremen, 28213

  • Novo Nordisk Investigational Site

    Dresden, 01219

  • Novo Nordisk Investigational Site

    Dresden, 01307

  • Novo Nordisk Investigational Site

    Duisburg, 47051

  • Novo Nordisk Investigational Site

    Ebersheim, 55129

  • Novo Nordisk Investigational Site

    Eisenach, 99817

  • Novo Nordisk Investigational Site

    Erfurt, 99085

  • Novo Nordisk Investigational Site

    Esslingen am Neckar, 73728

  • Novo Nordisk Investigational Site

    Frankfurt, 60388

  • Novo Nordisk Investigational Site

    Freiburg im Breisgau, 79106

  • Novo Nordisk Investigational Site

    Fulda, 36037

  • Novo Nordisk Investigational Site

    Gifhorn, 38518

  • Novo Nordisk Investigational Site

    Grevenbroich, 41515

  • Novo Nordisk Investigational Site

    Hamburg, 21073

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Jena, 07743

  • Novo Nordisk Investigational Site

    Leipzig, 04103

  • Novo Nordisk Investigational Site

    Leipzig, 04275

  • Novo Nordisk Investigational Site

    Limburg, 65549

  • Novo Nordisk Investigational Site

    Mainz, 55131

  • Novo Nordisk Investigational Site

    Mannheim, 68163

  • Novo Nordisk Investigational Site

    München, 81925

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Neuwied, 56564

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Rosenheim, 83022

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

  • Novo Nordisk Investigational Site

    Schkeuditz, 04435

  • Novo Nordisk Investigational Site

    Sinsheim, 74889

  • Novo Nordisk Investigational Site

    Stuttgart, 70184

  • Novo Nordisk Investigational Site

    Wangen, 88239

Other trials in Germany

United Kingdom32 sites

  • Novo Nordisk Investigational Site

    Aberdeen, AB25 1LD

  • Novo Nordisk Investigational Site

    Ashton-under-Lyne, OL6 9RW

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG

  • Novo Nordisk Investigational Site

    Belfast, BT12 6BA

  • Novo Nordisk Investigational Site

    Belfast, BT16 1RH

  • Novo Nordisk Investigational Site

    Belfast, BT41 2RL

  • Novo Nordisk Investigational Site

    Blackburn, BB2 3HH

  • Novo Nordisk Investigational Site

    Bradford, BD9 6RJ

  • Novo Nordisk Investigational Site

    Bristol, BS2 8HW

  • Novo Nordisk Investigational Site

    Coventry, CV2 2DX

  • Novo Nordisk Investigational Site

    Derby, DE22 3NE

  • Novo Nordisk Investigational Site

    Dundee, DD1 9SY

  • Novo Nordisk Investigational Site

    Edgbaston, Birmingham, B15 2TH

  • Novo Nordisk Investigational Site

    Edinburgh, EH4 2XU

  • Novo Nordisk Investigational Site

    Exeter, EX2 5AX

  • Novo Nordisk Investigational Site

    Guildford, GU2 7XX

  • Novo Nordisk Investigational Site

    Hull, HU3 2JZ

  • Novo Nordisk Investigational Site

    Inverness, IV2 3UJ

  • Novo Nordisk Investigational Site

    Leicester, LE1 5WW

  • Novo Nordisk Investigational Site

    Liverpool, L7 8XP

  • Novo Nordisk Investigational Site

    Liverpool, L9 7AL

  • Novo Nordisk Investigational Site

    London, E1 2EF

  • Novo Nordisk Investigational Site

    Londonderry, BT47 6SB

  • Novo Nordisk Investigational Site

    Manchester, M41 5SL

  • Novo Nordisk Investigational Site

    Manchester, M8 5RB

  • Novo Nordisk Investigational Site

    Northampton, NN1 5BD

  • Novo Nordisk Investigational Site

    Nuneaton, CV10 7DJ

  • Novo Nordisk Investigational Site

    Oxford, OX3 7LE

  • Novo Nordisk Investigational Site

    Rugby, CV22 5PX

  • Novo Nordisk Investigational Site

    Salford, M6 8HD

  • Novo Nordisk Investigational Site

    Swansea, SA6 6NL

  • Novo Nordisk Investigational Site

    Welwyn Garden City, AL7 4HQ

Other trials in United Kingdom

Spain25 sites

  • Novo Nordisk Investigational Site

    Almería, 04001

  • Novo Nordisk Investigational Site

    Badajoz, 06080

  • Novo Nordisk Investigational Site

    Badalona, 08916

  • Novo Nordisk Investigational Site

    Bilbao, 48013

  • Novo Nordisk Investigational Site

    Cadiz, 11009

  • Novo Nordisk Investigational Site

    Cartagena, 30203

  • Novo Nordisk Investigational Site

    Córdoba, 14004

  • Novo Nordisk Investigational Site

    Girona, 17007

  • Novo Nordisk Investigational Site

    Granada, 18012

  • Novo Nordisk Investigational Site

    Madrid, 28006

  • Novo Nordisk Investigational Site

    Madrid, 28031

  • Novo Nordisk Investigational Site

    Madrid, 28040

  • Novo Nordisk Investigational Site

    Majadahonda, 28222

  • Novo Nordisk Investigational Site

    Pamplona, 31008

  • Novo Nordisk Investigational Site

    Pontevedra, 36001

  • Novo Nordisk Investigational Site

    Pozuelo de Alarcón, 28223

  • Novo Nordisk Investigational Site

    Salamanca, 37007

  • Novo Nordisk Investigational Site

    San Juan, 03550

  • Novo Nordisk Investigational Site

    San Sebastián de los Reyes, 28700

  • Novo Nordisk Investigational Site

    Santa Cruz de Tenerife, 38010

  • Novo Nordisk Investigational Site

    Seville, 41013

  • Novo Nordisk Investigational Site

    Tarrasa, 08221

  • Novo Nordisk Investigational Site

    Valencia, 46010

  • Novo Nordisk Investigational Site

    Xátiva, 46800

  • Novo Nordisk Investigational Site

    Zaragoza, 50009

Other trials in Spain

France24 sites

  • Novo Nordisk Investigational Site

    Antibes, 06600

  • Novo Nordisk Investigational Site

    Bron, 69677

  • Novo Nordisk Investigational Site

    Cahors, 46005

  • Novo Nordisk Investigational Site

    Corbeil-Essonnes, 91106

  • Novo Nordisk Investigational Site

    Haguenau, 67504

  • Novo Nordisk Investigational Site

    La Rochelle, 17019

  • Novo Nordisk Investigational Site

    Le Creusot, 71200

  • Novo Nordisk Investigational Site

    Marseille, 13008

  • Novo Nordisk Investigational Site

    Marseille, 13285

  • Novo Nordisk Investigational Site

    Montpellier, 34070

  • Novo Nordisk Investigational Site

    Montpellier, 34295

  • Novo Nordisk Investigational Site

    Narbonne, 11108

  • Novo Nordisk Investigational Site

    Paris, 75181

  • Novo Nordisk Investigational Site

    Paris, 75475

  • Novo Nordisk Investigational Site

    Perpignan, 66046

  • Novo Nordisk Investigational Site

    Pessac, 33600

  • Novo Nordisk Investigational Site

    Poitiers, 86000

  • Novo Nordisk Investigational Site

    Reims, 51056

  • Novo Nordisk Investigational Site

    Saint Quentin Cédex, 02321

  • Novo Nordisk Investigational Site

    Saint-denis de La Reunion, 97405

  • Novo Nordisk Investigational Site

    Saint-pierre de La Reunion, 97448

  • Novo Nordisk Investigational Site

    Sète, 34200

  • Novo Nordisk Investigational Site

    Strasbourg, 67000

  • Novo Nordisk Investigational Site

    Tours, 37044

Other trials in France

Italy21 sites

  • Novo Nordisk Investigational Site

    Ancona, 60100

  • Novo Nordisk Investigational Site

    Caserta, 81100

  • Novo Nordisk Investigational Site

    Catanzaro, 88100

  • Novo Nordisk Investigational Site

    Catanzaro Lido

  • Novo Nordisk Investigational Site

    Chiavari, 16043

  • Novo Nordisk Investigational Site

    Cosenza, 87100

  • Novo Nordisk Investigational Site

    Ferrara

  • Novo Nordisk Investigational Site

    Lanciano

  • Novo Nordisk Investigational Site

    Matera (mt), 75100

  • Novo Nordisk Investigational Site

    Milan, 20162

  • Novo Nordisk Investigational Site

    Milan

  • Novo Nordisk Investigational Site

    Monserrato, Cagliari, 09042

  • Novo Nordisk Investigational Site

    Monza, 20052

  • Novo Nordisk Investigational Site

    Palermo, 90127

  • Novo Nordisk Investigational Site

    Piacenza, 29100

  • Novo Nordisk Investigational Site

    Primo Piano Palazzina Ambulato, 40133

  • Novo Nordisk Investigational Site

    Ravenna, 48121

  • Novo Nordisk Investigational Site

    Reggio Calabria, 89122

  • Novo Nordisk Investigational Site

    Roma, 00133

  • Novo Nordisk Investigational Site

    Terni, 05100

  • Novo Nordisk Investigational Site

    Treviglio

Other trials in Italy

Netherlands20 sites

  • Novo Nordisk Investigational Site

    Amersfoort, 3816 CP

  • Novo Nordisk Investigational Site

    Amsterdam, 1091 HA

  • Novo Nordisk Investigational Site

    Amsterdam, 1105 AZ

  • Novo Nordisk Investigational Site

    Beek, 6191JW

  • Novo Nordisk Investigational Site

    Delft, 2625 AD

  • Novo Nordisk Investigational Site

    Doetinchem, 7001 GW

  • Novo Nordisk Investigational Site

    Eindhoven, 5616 GB

  • Novo Nordisk Investigational Site

    Groningen, 9728 NT

  • Novo Nordisk Investigational Site

    Heerlen, 6419 PC

  • Novo Nordisk Investigational Site

    Hoofddorp, 2134 TM

  • Novo Nordisk Investigational Site

    Hoogeveen, 7909 AA

  • Novo Nordisk Investigational Site

    Leiden, 2334 CK

  • Novo Nordisk Investigational Site

    Leiderdorp, 2352 RA

  • Novo Nordisk Investigational Site

    Lichtenvoorde, 7131 CM

  • Novo Nordisk Investigational Site

    Lieshout, 5737 CB

  • Novo Nordisk Investigational Site

    Oude Pekela, 9665 AR

  • Novo Nordisk Investigational Site

    Utrecht, 3584 CX

  • Novo Nordisk Investigational Site

    Voorburg, 2275 CX

  • Novo Nordisk Investigational Site

    Wildervank, 9648 BE

  • Novo Nordisk Investigational Site

    Winschoten, 9671 CX

Other trials in Netherlands

Canada7 sites

  • Novo Nordisk Investigational Site

    Ajax, L1S 7K8

  • Novo Nordisk Investigational Site

    Edmonton, Alberta, T5J 3N4

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novo Nordisk Investigational Site

    London, Ontario, N6G 2M1

  • Novo Nordisk Investigational Site

    Mississauga, Ontario, L5M 2V8

  • Novo Nordisk Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Puerto Rico3 sites

  • Novo Nordisk Investigational Site

    Bayamón, 00961

  • Novo Nordisk Investigational Site

    Carolina, 00983

  • Novo Nordisk Investigational Site

    Trujillo Alto, 00976

Other trials in Puerto Rico

Belgium2 sites

  • Novo Nordisk Investigational Site

    Bonheiden, 2820

  • Novo Nordisk Investigational Site

    Leuven, 3000

Other trials in Belgium

About this study

Official title: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.

Being tested
liraglutide, insulin detemir, 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

    Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.

  • insulin detemirDrug

    Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm

  • metforminDrug

    Metformin tablets, at least 1500 mg/day

Study groups in NCT00856986
Study groupRoleWhat they receive
Lira 1.8ExperimentalSubcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Receives: Drug: liraglutide; Drug: metformin
Insulin detemir + Lira 1.8ExperimentalSubcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Receives: Drug: liraglutide; Drug: insulin detemir; Drug: metformin
Non-Randomised Lira 1.8ExperimentalSubcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Receives: Drug: liraglutide; Drug: metformin
Early Withdrawals Lira 1.8OtherSubcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Receives: Drug: liraglutide; Drug: metformin
Intensified groupOtherIntensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Receives: Drug: liraglutide; Drug: insulin detemir; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.

    Measured: Week 0 (Randomisation), week 26

Secondary outcomes (31)

  1. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)

    Measured: Week 0, Week 52

  2. Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)

    Measured: Week 0, Week 52

  3. Mean Change From Randomisation in Fasting Plasma Glucose at Week 26

    Measured: Week 0 (Randomisation), Week 26

  4. Mean Change From Randomisation in Fasting Plasma Glucose at Week 52

    Measured: Week 0, Week 52

  5. Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26

    Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.

    Measured: Week 0 (Randomisation), Week 26

  6. Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52

    Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.

    Measured: Week 0, Week 52

  7. Mean Change From Randomisation in Fasting Insulin at Week 26

    Measured: Week 0 (Randomisation), Week 26

  8. Mean Change From Randomisation in Fasting Insulin at Week 52

    Measured: Week 0 (Randomisation), Week 52

  9. Mean Change From Randomisation in Fasting Pro-insulin at Week 26.

    Measured: Week 0 (Randomisation), Week 26

  10. Mean Change From Randomisation in Fasting Pro-insulin at Week 52

    Measured: Week 0, Week 52

  11. Mean Change From Randomisation in Fasting C-peptide at Week 26.

    Measured: Week 0 (Randomisation), Week 26

  12. Mean Change From Randomisation in Fasting C-peptide at Week 52.

    Measured: Week 0, Week 52

  13. Mean Changes From Randomisation in Cholesterol Lipids at Week 26.

    Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)

    Measured: Week 0 (Randomisation), Week 26

  14. Mean Changes From Randomisation in Cholesterol Lipids at Week 52.

    Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)

    Measured: Week 0, Week 52

  15. Mean Change From Randomisation in Lipids: Triglycerides at Week 26

    Measured: Week 0 (Randomisation), Week 26

  16. Mean Change From Randomisation in Lipids: Triglycerides at Week 52

    Measured: Week 0, Week 52

  17. Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26

    Measured: Week 0 (Randomisation), Week 26

  18. Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52

    Measured: Week 0, Week 52

  19. Mean Change From Randomisation in Body Weight at Week 26

    Measured: Week 0 (Randomisation), Week 26

  20. Mean Change From Randomisation in Body Weight at Week 52

    Measured: Week 0, Week 52

  21. Mean Change From Randomisation in Waist Circumference at Week 26.

    Measured: Week 0 (Randomisation), Week 26

  22. Mean Change From Randomisation in Waist Circumference at Week 52.

    Measured: Week 0, Week 52

  23. Mean Change From Randomisation in Hip Circumference at Week 26

    Measured: Week 0 (Randomisation), Week 26

  24. Mean Change From Randomisation in Hip Circumference at Week 52

    Measured: Week 0, week 52

  25. Mean Change From Randomisation in Waist to Hip Ratio at Week 26

    Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference

    Measured: Week 0 (Randomisation), Week 26

  26. Mean Change From Randomisation in Waist to Hip Ratio at Week 52

    Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference

    Measured: Week 0, Week 52

  27. Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.

    Measured: Week 0 (Randomisation), Week 26

  28. Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.

    Measured: Week 0, Week 52

  29. Adverse Events From Run-in (Week -12) to Week 52

    Measured: Run-in (week -12) to Week 52

  30. 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

  31. Hypoglycaemic 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: Week 0-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionApr 2010
  4. Study completionNov 2010

Resources

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
987 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856986
Sponsor's protocol ID
NN2211-1842
Other IDs
2007-005317-19
Status last verified
Jan 2017
First submitted
5 Mar 2009
Last updated
8 Mar 2017
Data monitoring committee
No

Publications

  • DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012 Jul;35(7):1446-54. doi: 10.2337/dc11-1928. Epub 2012 May 14.

    PubMed 22584132

  • Rosenstock J, Rodbard HW, Bain SC, D'Alessio D, Seufert J, Thomsen AB, Svendsen CB, DeVries JH; Liraglutide-Detemir Study Group. One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. J Diabetes Complications. 2013 Sep-Oct;27(5):492-500. doi: 10.1016/j.jdiacomp.2013.04.008. Epub 2013 Jun 6.

    PubMed 23746555

  • Jensen 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 25504028

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide, insulin detemir and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 233 sites in 10 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 3 inclusion and 9 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 233 sites in United States, Germany, United Kingdom, Spain, France and 5 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 13 May 2011). 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 Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. (time frame: Week 0 (Randomisation), week 26). 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 NCT00856986, which also lists 3 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.

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