DiabetesPhase 2NCT02461589

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

A Phase 2 study testing semaglutide and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 150 sites in 10 countries.

Completed

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

Official record

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Trial summary

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: semaglutide and liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 706 participants
Where: 150 sitesin 10 countries
Study dates: 21 Sep 2015to 13 Oct 2016
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age at least 18 years at the time of signing informed consent.
Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Who cannot join

Simultaneous participation in any other clinical trial of an investigational medicinal product
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
History of pancreatitis (acute or chronic)
Screening calcitonin above or equal to 50 ng/L

Show all 11Show fewer

Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Currently planned coronary, carotid or peripheral artery revascularisation
Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Trial locations and contacts

150 sites in 10 countries.

Country

City, postcode or hospital

150 sites in 10 countries

United States84 sites

Novo Nordisk Investigational Site
Arlington, Texas, 76012-4637
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Austin, Texas, 78705
Novo Nordisk Investigational Site
Belzoni, Mississippi, 39038
Novo Nordisk Investigational Site
Birmingham, Alabama, 35209
Novo Nordisk Investigational Site
Birmingham, Alabama, 35294
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Boston, Massachusetts, 02215
Novo Nordisk Investigational Site
Bountiful, Utah, 84010
Novo Nordisk Investigational Site
Bridgeton, Missouri, 63044
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Buckley, Michigan, 49620
Novo Nordisk Investigational Site
Carrollton, Texas, 75010
Novo Nordisk Investigational Site
Charleston, South Carolina, 29412
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45219
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45227
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45255
Novo Nordisk Investigational Site
Clinton, Utah, 84015
Novo Nordisk Investigational Site
Coronado, California, 92118
Novo Nordisk Investigational Site
Corvallis, Oregon, 97330-3737
Novo Nordisk Investigational Site
Dallas, Texas, 75220
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Delaware, Ohio, 43015
Novo Nordisk Investigational Site
Downingtown, Pennsylvania, 19335-2620
Novo Nordisk Investigational Site
Dublin, Ohio, 43016
Novo Nordisk Investigational Site
Elkhorn, Nebraska, 68022
Novo Nordisk Investigational Site
Evanston, Illinois, 60201-2477
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Gainesville, Florida, 32609
Novo Nordisk Investigational Site
Gainesville, Florida, 32653
Novo Nordisk Investigational Site
Hartford, Connecticut, 06105
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Hodges, South Carolina, 29653
Novo Nordisk Investigational Site
Hopewell Junction, New York, 12553
Novo Nordisk Investigational Site
Houston, Texas, 77008
Novo Nordisk Investigational Site
Johnson City, Tennessee, 37604
Novo Nordisk Investigational Site
Kalispell, Montana, 59901
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Lancaster, California, 93534
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89103
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Louisville, Kentucky, 40206
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Marietta, Georgia, 30067
Novo Nordisk Investigational Site
Marrero, Louisiana, 70072
Novo Nordisk Investigational Site
Mason, Ohio, 45040-6815
Novo Nordisk Investigational Site
Media, Pennsylvania, 19063
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119-4806
Novo Nordisk Investigational Site
Miami, Florida, 33173
Novo Nordisk Investigational Site
Miami, Florida, 33183
Novo Nordisk Investigational Site
Missouri City, Texas, 77459
Novo Nordisk Investigational Site
Mt. Pleasant, South Carolina, 29464
Novo Nordisk Investigational Site
Nashville, Tennessee, 37203
Novo Nordisk Investigational Site
New Braunfels, Texas, 78130
Novo Nordisk Investigational Site
Newton, Kansas, 67114
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73112
Novo Nordisk Investigational Site
Old Point Station, South Carolina, 29707
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33026
Novo Nordisk Investigational Site
Ponte Vedra, Florida, 32081
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Richmond, Virginia, 23219
Novo Nordisk Investigational Site
Riverside, California, 92506
Novo Nordisk Investigational Site
Riverton, Utah, 84065
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
San Antonio, Texas, 78230
Novo Nordisk Investigational Site
San Antonio, Texas, 78258
Novo Nordisk Investigational Site
Slidell, Louisiana, 70458
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Smithfield, Pennsylvania, 15478
Novo Nordisk Investigational Site
Spokane, Washington, 99216-1557
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Uniontown, Pennsylvania, 15401
Novo Nordisk Investigational Site
Van Nuys, California, 91405
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23454
Novo Nordisk Investigational Site
Vista, California, 92083
Novo Nordisk Investigational Site
Waco, Texas, 76710
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Winchester, Virginia, 22601

Other trials in United States

United Kingdom13 sites

Novo Nordisk Investigational Site
Basingstoke, RG24 9GT
Novo Nordisk Investigational Site
Belfast, BT16 1RH
Novo Nordisk Investigational Site
Bexhill-on-Sea, TN39 4SP
Novo Nordisk Investigational Site
Blackburn, BB2 1AX
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Chesterfield, Derbyshire, S40 4AA
Novo Nordisk Investigational Site
Devon, EX2 5DW
Novo Nordisk Investigational Site
Harrogate, North Yorkshire, HG2 7SX
Novo Nordisk Investigational Site
Hinckley, LE10 2SE
Novo Nordisk Investigational Site
Oxford, OX3 7LE
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Sidcup, DA14 6LT
Novo Nordisk Investigational Site
Truro, TR1 3LJ

Other trials in United Kingdom

Czechia9 sites

Novo Nordisk Investigational Site
Benešov, 25601
Novo Nordisk Investigational Site
Brno, 602 00
Novo Nordisk Investigational Site
Liberec, 46001
Novo Nordisk Investigational Site
Náchod, 54701
Novo Nordisk Investigational Site
Pilsen, 301 00
Novo Nordisk Investigational Site
Police nad Metují, 54954
Novo Nordisk Investigational Site
Prague, 140 46
Novo Nordisk Investigational Site
Prague, 150 00
Novo Nordisk Investigational Site
Trutnov, 541 01

Other trials in Czechia

Germany9 sites

Novo Nordisk Investigational Site
Eisenach, 99817
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Pohlheim, 35415
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
Novo Nordisk Investigational Site
Stuttgart, 70378
Novo Nordisk Investigational Site
Sulzbach-Rosenberg, 92237

Other trials in Germany

Canada8 sites

Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
Hamilton, Ontario, L8K 3P3
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Laval, Quebec, H7T 2P5
Novo Nordisk Investigational Site
Moncton, New Brunswick, E1G 1A7
Novo Nordisk Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Novo Nordisk Investigational Site
Sarnia, Ontario, N7T 4X3
Novo Nordisk Investigational Site
Strathroy, Ontario, N7G 1Y7

Other trials in Canada

Russia8 sites

Novo Nordisk Investigational Site
Dzerzhinskiy, 140091
Novo Nordisk Investigational Site
Kazan', 420073
Novo Nordisk Investigational Site
Saint Petersburg, 191119
Novo Nordisk Investigational Site
Saratov, 410031
Novo Nordisk Investigational Site
Saratov, 410039
Novo Nordisk Investigational Site
Smolensk, 214031
Novo Nordisk Investigational Site
Syktyvkar, 167981
Novo Nordisk Investigational Site
Voronezh, 394018

Other trials in Russia

South Africa6 sites

Novo Nordisk Investigational Site
Bloemfontein, Free State, 9301
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4092
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4450
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1812
Novo Nordisk Investigational Site
Middleburg, Mpumalanga, 1055
Novo Nordisk Investigational Site
Midrand, Gauteng, 1685

Other trials in South Africa

Malaysia5 sites

Novo Nordisk Investigational Site
George Town, 10450
Novo Nordisk Investigational Site
Klang, Selangor, 41200
Novo Nordisk Investigational Site
Kota Bharu, 15586
Novo Nordisk Investigational Site
Seremban, 70300
Novo Nordisk Investigational Site
Seri Manjung, 32040

Other trials in Malaysia

Serbia5 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Niš, 18000
Novo Nordisk Investigational Site
Novi Sad, 21000
Novo Nordisk Investigational Site
Zaječar, 19000

Other trials in Serbia

Austria3 sites

Novo Nordisk Investigational Site
Graz, 8010
Novo Nordisk Investigational Site
Saint Stefan, 8511
Novo Nordisk Investigational Site
Vienna, 1130

Other trials in Austria

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: semaglutide, liraglutide, placebo
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.

semaglutideDrug
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
liraglutideDrug
Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
placeboDrug
Administered subcutaneously ( s.c., under the skin) once daily.

Study groups in NCT02461589
Study group	Role	What they receive
Semaglutide 0.05 mg/day	Experimental	Not described Receives: Drug: semaglutide
Liraglutide 0.3 mg/day	Active comparator	Not described Receives: Drug: liraglutide
Placebo 50 µL	Placebo comparator	Not described Receives: Drug: placebo
Semaglutide 0.05/0.1 mg/day	Experimental	Not described Receives: Drug: semaglutide
Liraglutide 0.3/0.6 mg/day	Active comparator	Not described Receives: Drug: liraglutide
Placebo 50/100 µL	Placebo comparator	Not described Receives: Drug: placebo
Semaglutide 0.05/0.1/0.2 mg/day	Experimental	Not described Receives: Drug: semaglutide
Liraglutide 0.3/0.6/1.2 mg/day	Active comparator	Not described Receives: Drug: liraglutide
Placebo 50/100/200 µL	Placebo comparator	Not described Receives: Drug: placebo
Semaglutide 0.05/0.1/0.2/0.3 mg/day	Experimental	Not described Receives: Drug: semaglutide
Liraglutide 0.3/0.6/1.2/1.8 mg/day	Active comparator	Not described Receives: Drug: liraglutide
Placebo 50/100/200/300 µL	Placebo comparator	Not described Receives: Drug: placebo
Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day	Experimental	Not described Receives: Drug: semaglutide

What is being measured

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

Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Measured: Week 0, week 26

Secondary outcomes (3)

Change in Fasting Plasma Glucose (FPG)
Estimated mean change from baseline in FPG at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Measured: Week 0, Week 26
Body Weight Change
The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Measured: Week 0, Week 26
Change in Systolic and Diastolic Blood Pressure
The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Measured: Week 0, Week 26

Timeline

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

21 Sep 201513 Oct 2016

First posted3 Jun 2015 (estimated)
Study start21 Sep 2015
Primary completion13 Oct 2016
Study completion13 Oct 2016

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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 706 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02461589
Sponsor's protocol ID: NN9535-4191
Other IDs: 2014-003196-39, U1111-1159-4923, 2014
Status last verified: Jul 2019
First submitted: 1 Jun 2015
Last updated: 31 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lingvay I, Desouza CV, Lalic KS, Rose L, Hansen T, Zacho J, Pieber TR. A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin. Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 19.
PubMed 30026333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02461589
Acronym / sponsor ID: NN9535-4191
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 706 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 13 Oct 2016 (actual)
Study completion: 13 Oct 2016 (actual)
First posted: 3 Jun 2015 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 13

Arm	Type	Receives
Semaglutide 0.05 mg/day	Experimental	Drug: semaglutide
Liraglutide 0.3 mg/day	Active comparator	Drug: liraglutide
Placebo 50 µL	Placebo comparator	Drug: placebo
Semaglutide 0.05/0.1 mg/day	Experimental	Drug: semaglutide
Liraglutide 0.3/0.6 mg/day	Active comparator	Drug: liraglutide
Placebo 50/100 µL	Placebo comparator	Drug: placebo
Semaglutide 0.05/0.1/0.2 mg/day	Experimental	Drug: semaglutide
Liraglutide 0.3/0.6/1.2 mg/day	Active comparator	Drug: liraglutide
Placebo 50/100/200 µL	Placebo comparator	Drug: placebo
Semaglutide 0.05/0.1/0.2/0.3 mg/day	Experimental	Drug: semaglutide
Liraglutide 0.3/0.6/1.2/1.8 mg/day	Active comparator	Drug: liraglutide
Placebo 50/100/200/300 µL	Placebo comparator	Drug: placebo
Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day	Experimental	Drug: semaglutide

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, age at least 18 years at the time of signing informed consent.
Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

Key exclusion criteria (11 listed)

Simultaneous participation in any other clinical trial of an investigational medicinal product
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
History of pancreatitis (acute or chronic)

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
semaglutideAdministered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.	Drug	Semaglutide 0.05 mg/day, Semaglutide 0.05/0.1 mg/day, Semaglutide 0.05/0.1/0.2 mg/day, Semaglutide 0.05/0.1/0.2/0.3 mg/day, Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day
liraglutideAdministered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.	Drug	Liraglutide 0.3 mg/day, Liraglutide 0.3/0.6 mg/day, Liraglutide 0.3/0.6/1.2 mg/day, Liraglutide 0.3/0.6/1.2/1.8 mg/day
placeboAdministered subcutaneously ( s.c., under the skin) once daily.	Drug	Placebo 50 µL, Placebo 50/100 µL, Placebo 50/100/200 µL, Placebo 50/100/200/300 µL

Primary outcome

Change in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 26
Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.

3 secondary outcomes

Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26
Body Weight Change
Time frame: Week 0, Week 26
Change in Systolic and Diastolic Blood Pressure
Time frame: Week 0, Week 26

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide 0.05 mg/Day	64	58
Semaglutide 0.1 mg/Day	63	61
Semaglutide 0.2 mg/Day	65	60
Semaglutide 0.3 mg/Day	63	58
Liraglutide 0.3 mg/Day	64	62
Liraglutide 0.6 mg/Day	64	61
Liraglutide 1.2 mg/Day	64	58
Liraglutide 1.8 mg/Day	65	60
Placebo	129	123
Semaglutide Flexible	65	60

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	Semaglutide 0.05 mg/Day n = 64	Semaglutide 0.1 mg/Day n = 63	Semaglutide 0.2 mg/Day n = 65	Semaglutide 0.3 mg/Day n = 63	Liraglutide 0.3 mg/Day n = 64	Liraglutide 0.6 mg/Day n = 64	Liraglutide 1.2 mg/Day n = 64	Liraglutide 1.8 mg/Day n = 65	Placebo n = 129	Semaglutide Flexible n = 64
Value	-0.97 (0.85)	-1.30 (1.03)	-1.65 (0.79)	-1.96 (0.95)	-0.50 (0.93)	-0.88 (0.90)	-0.86 (0.92)	-1.32 (0.78)	-0.05 (0.90)	-1.72 (0.97)

Semaglutide 0.05 mg/Day vs Placebo: Treatment difference: -1.04 (95% CI -1.30 to -0.77), p <0.0001, Mixed Models Analysis
Semaglutide 0.1 mg/Day vs Placebo: Treatment difference: -1.34 (95% CI -1.61 to -1.08), p <0.0001, Mixed Models Analysis
Semaglutide 0.2 mg/Day vs Placebo: Treatment difference: -1.69 (95% CI -1.95 to -1.42), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to week 33.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide 0.05 mg/Day	7 of 64 (10.9%)	31 of 64 (48.4%)	Not reported
Semaglutide 0.1 mg/Day	3 of 63 (4.8%)	34 of 63 (54%)	Not reported
Semaglutide 0.2 mg/Day	2 of 65 (3.1%)	39 of 65 (60%)	Not reported
Semaglutide 0.3 mg/Day	2 of 63 (3.2%)	42 of 63 (66.7%)	Not reported
Liraglutide 0.3 mg/Day	1 of 64 (1.6%)	33 of 64 (51.6%)	Not reported
Liraglutide 0.6 mg/Day	2 of 64 (3.1%)	27 of 64 (42.2%)	Not reported
Liraglutide 1.2 mg/Day	2 of 64 (3.1%)	35 of 64 (54.7%)	Not reported
Liraglutide 1.8 mg/Day	7 of 65 (10.8%)	35 of 65 (53.8%)	Not reported
Placebo	0 of 129 (0%)	0 of 129 (0%)	Not reported
Semaglutide Flexible	4 of 64 (6.3%)	44 of 64 (68.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30026333Lingvay I, Desouza CV, Lalic KS, Rose L, Hansen T, Zacho J, Pieber TR. A 26-Week Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or Without Metformin. Diabetes Care. 2018 Sep;41(9):1926-1937. doi: 10.2337/dc17-2381. Epub 2018 Jul 19.
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

150 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaglutide and liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 150 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 4 inclusion and 11 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, United Kingdom, Czechia, Germany, Canada 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Jan 2018). 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?

Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, 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 NCT02461589, which also lists 1 linked publication.

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 31 Jul 2019.