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CompletedNCT02461589Updated Jul 31, 2019Results posted

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

A Phase 2 interventional study of semaglutide and liraglutide in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 150 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
706
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 706 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
706 participants (actual)

Study arms

  • Experimental
    Semaglutide 0.05 mg/day

    Drug: semaglutide

  • Active comparator
    Liraglutide 0.3 mg/day

    Drug: liraglutide

  • Placebo comparator
    Placebo 50 µL

    Drug: placebo

  • Experimental
    Semaglutide 0.05/0.1 mg/day

    Drug: semaglutide

  • Active comparator
    Liraglutide 0.3/0.6 mg/day

    Drug: liraglutide

  • Placebo comparator
    Placebo 50/100 µL

    Drug: placebo

  • Experimental
    Semaglutide 0.05/0.1/0.2 mg/day

    Drug: semaglutide

  • Active comparator
    Liraglutide 0.3/0.6/1.2 mg/day

    Drug: liraglutide

  • Placebo comparator
    Placebo 50/100/200 µL

    Drug: placebo

  • Experimental
    Semaglutide 0.05/0.1/0.2/0.3 mg/day

    Drug: semaglutide

  • Active comparator
    Liraglutide 0.3/0.6/1.2/1.8 mg/day

    Drug: liraglutide

  • Placebo comparator
    Placebo 50/100/200/300 µL

    Drug: placebo

  • Experimental
    Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

    Drug: semaglutide

Interventions

  • Drugsemaglutide

    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.

  • Drugliraglutide

    Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

  • Drugplacebo

    Administered subcutaneously ( s.c., under the skin) once daily.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 0, week 26

Secondary outcomes

  1. 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.

    Time frame: Week 0, Week 26

  2. 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.

    Time frame: Week 0, Week 26

  3. 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.

    Time frame: Week 0, Week 26

07

Results

Posted Jan 23, 2018

Participant flow

The trial was conducted at 139 sites in 10 countries as follows: Austria: 3 sites; Canada: 8 sites; Czech Republic: 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.

Participant flow — Overall Study
MilestoneSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Started646365636464646512965
Exposed646365636464646512964
Completed586160586261586012360
Not completed6255236565
Withdrew: Withdrawal by subject5132121331
Withdrew: Lost to follow-up0023113131
Withdrew: Death0000000100
Withdrew: Unclassified0000001002
Withdrew: Missing follow-up information1100001000
Withdrew: Withdrawal from trial before exposure0000000001

Outcome measures

PrimaryChange 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.

Time frame:
Week 0, week 26
Reported as:
Mean · percentage of glycosylated haemoglobin
Change in HbA1c (Glycosylated Haemoglobin)
percentage of glycosylated haemoglobinSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Change in HbA1c (Glycosylated Haemoglobin)-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
Statistical analysis
  • Semaglutide 0.05 mg/Day vs Placebo · Mixed Models Analysis · p = <0.0001 · Treatment difference: -1.04 · 95% CI -1.30 to -0.77
  • Semaglutide 0.1 mg/Day vs Placebo · Mixed Models Analysis · p = <0.0001 · Treatment difference: -1.34 · 95% CI -1.61 to -1.08
  • Semaglutide 0.2 mg/Day vs Placebo · Mixed Models Analysis · p = <0.0001 · Treatment difference: -1.69 · 95% CI -1.95 to -1.42
  • Semaglutide 0.3 mg/Day vs Placebo · Mixed Models Analysis · p = <0.0001 · Treatment difference: -1.86 · 95% CI -2.12 to -1.60
SecondaryChange 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.

Time frame:
Week 0, Week 26
Reported as:
Mean · mmol/L
Change in Fasting Plasma Glucose (FPG)
mmol/LSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Change in Fasting Plasma Glucose (FPG)-2.09 ± 1.96-2.08 ± 2.23-2.64 ± 2.07-3.53 ± 2.20-1.33 ± 2.06-1.56 ± 1.74-1.51 ± 2.41-1.92 ± 2.34-0.54 ± 2.45-3.40 ± 2.84
SecondaryBody 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.

Time frame:
Week 0, Week 26
Reported as:
Mean · kg
Body Weight Change
kgSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Body Weight Change-2.75 ± 2.82-4.36 ± 4.24-6.70 ± 4.57-8.23 ± 5.34-1.48 ± 3.06-1.81 ± 3.06-1.78 ± 3.41-3.68 ± 4.26-1.22 ± 3.42-6.60 ± 4.98
SecondaryChange 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.

Time frame:
Week 0, Week 26
Reported as:
Mean · mmHg
Change in Systolic and Diastolic Blood Pressure
mmHgSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Systolicblood pressure-5.74 ± 12.30-2.77 ± 13.21-4.25 ± 12.24-9.85 ± 11.58-3.77 ± 9.79-3.20 ± 10.89-4.69 ± 12.73-2.99 ± 11.94-2.34 ± 11.40-6.62 ± 14.02
Diastolic blood pressure-0.60 ± 8.780.66 ± 8.26-1.62 ± 9.38-4.02 ± 8.56-1.77 ± 7.37-1.89 ± 8.20-0.60 ± 6.780.63 ± 8.13-0.61 ± 8.50-1.69 ± 8.25

Adverse events

Collected over From baseline up to week 33.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Semaglutide 0.05 mg/Day—7/64 (10.9%)31/64 (48.4%)
Semaglutide 0.1 mg/Day—3/63 (4.8%)34/63 (54%)
Semaglutide 0.2 mg/Day—2/65 (3.1%)39/65 (60%)
Semaglutide 0.3 mg/Day—2/63 (3.2%)42/63 (66.7%)
Liraglutide 0.3 mg/Day—1/64 (1.6%)33/64 (51.6%)
Liraglutide 0.6 mg/Day—2/64 (3.1%)27/64 (42.2%)
Liraglutide 1.2 mg/Day—2/64 (3.1%)35/64 (54.7%)
Liraglutide 1.8 mg/Day—7/65 (10.8%)35/65 (53.8%)
Placebo—0/129 (0%)0/129 (0%)
Semaglutide Flexible—4/64 (6.3%)44/64 (68.8%)
Most frequent serious events
Showing 10 of 41
Most frequent serious events
EventSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
Anal fistulaGastrointestinal disorders0/641/630/650/630/640/640/640/650/1290/64
Atrioventricular block completeCardiac disorders0/640/630/651/630/640/640/640/650/1290/64
CystoscopyInvestigations0/641/630/650/630/640/640/640/650/1290/64
Escherichia pyelonephritisInfections and infestations0/641/630/650/630/640/640/640/650/1290/64
Spinal meningioma benignNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/640/630/651/630/640/640/640/650/1290/64
Abortion spontaneousPregnancy, puerperium and perinatal conditions1/640/630/650/630/640/640/640/650/1290/64
Acute myocardial infarctionCardiac disorders1/640/630/650/630/640/641/641/650/1290/64
ArteriosclerosisVascular disorders1/640/630/650/630/640/640/640/650/1290/64
Carotid artery stenosisNervous system disorders1/640/630/650/630/640/640/640/650/1290/64
Clear cell renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/640/630/650/630/640/640/640/650/1291/64
Most frequent other events
Showing 10 of 25
Most frequent other events
EventSemaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide Flexible
NauseaGastrointestinal disorders11/6412/6314/6516/636/647/647/6413/650/12925/64
DiarrhoeaGastrointestinal disorders7/6410/6310/6516/635/645/645/648/650/12911/64
HeadacheNervous system disorders7/648/634/657/635/643/6410/644/650/1297/64
NasopharyngitisInfections and infestations7/646/634/655/634/643/645/645/650/12910/64
Decreased appetiteMetabolism and nutrition disorders3/647/636/658/632/641/643/643/650/1299/64
Upper respiratory tract infectionInfections and infestations7/642/631/657/636/641/642/645/650/1294/64
VomitingGastrointestinal disorders6/644/636/656/631/647/641/645/650/1296/64
ConstipationGastrointestinal disorders2/644/636/655/630/643/641/647/650/1294/64
Lipase increasedInvestigations3/643/633/653/633/643/644/647/650/1295/64
DyspepsiaGastrointestinal disorders1/645/635/656/632/643/641/643/650/1294/64

Baseline characteristics

Analysis was performed on the full analysis set (FAS) which included all randomised subjects who had received at least 1 dose of either semaglutide, liraglutide or placebo.

Age, Continuous
Age, Continuous(years)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean57.53 ± 9.857.51 ± 10.058.37 ± 9.5854.76 ± 9.6657.20 ± 10.7859.45 ± 9.7753.73 ± 11.3555.82 ± 9.1957.08 ± 9.2554.81 ± 9.7056.67 ± 9.94
Sex: Female, Male
Sex: Female, Male(Participants)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Female31282231353230325728326
Male33354332293234337236379
HbA1c (glycosylated haemoglobin)
HbA1c (glycosylated haemoglobin)(percentage of HbA1c)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean7.87 ± 0.717.91 ± 0.837.96 ± 0.828.23 ± 0.808.06 ± 0.868.12 ± 0.818.14 ± 0.878.07 ± 0.858.12 ± 0.878.10 ± 0.918.06 ± 0.84
Fasting plasma glucose
Fasting plasma glucose(mmol/L)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean9.26 ± 2.608.97 ± 2.229.20 ± 2.289.67 ± 2.569.32 ± 2.549.34 ± 2.339.91 ± 2.709.18 ± 2.459.67 ± 2.989.82 ± 2.669.45 ± 2.59
Body weight
Body weight(kg)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean93.44 ± 18.2792.40 ± 17.2098.07 ± 17.9294.82 ± 17.8492.25 ± 17.4892.68 ± 16.4696.67 ± 18.2893.40 ± 19.3493.98 ± 17.7595.29 ± 15.4394.28 ± 17.61
Systolic blood pressure
Systolic blood pressure(mmHg)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean133.70 ± 15.14130.97 ± 14.92131.34 ± 12.55132.08 ± 11.69134.02 ± 11.30132.41 ± 12.37134.20 ± 12.73131.02 ± 11.86132.17 ± 14.26132.70 ± 12.74132.43 ± 13.10
Diastolic blood pressure
Diastolic blood pressure(mmHg)Semaglutide 0.05 mg/DaySemaglutide 0.1 mg/DaySemaglutide 0.2 mg/DaySemaglutide 0.3 mg/DayLiraglutide 0.3 mg/DayLiraglutide 0.6 mg/DayLiraglutide 1.2 mg/DayLiraglutide 1.8 mg/DayPlaceboSemaglutide FlexibleTotal
Mean80.06 ± 8.9079.71 ± 8.5680.48 ± 8.8781.41 ± 8.0581.83 ± 6.9881.28 ± 6.9082.98 ± 6.9480.66 ± 7.6280.98 ± 8.0081.89 ± 8.4081.11 ± 7.96
08

Study locations

150 sites
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35209, United States
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35294, United States
  • Novo Nordisk Investigational Site
    Coronado, California 92118, United States
  • Novo Nordisk Investigational Site
    Lancaster, California 93534, United States
  • Novo Nordisk Investigational Site
    Riverside, California 92506, United States
  • Novo Nordisk Investigational Site
    Tustin, California 92780, United States
  • Novo Nordisk Investigational Site
    Van Nuys, California 91405, United States
  • Novo Nordisk Investigational Site
    Vista, California 92083, United States
  • Novo Nordisk Investigational Site
    Walnut Creek, California 94598, United States
  • Novo Nordisk Investigational Site
    Hartford, Connecticut 06105, United States
  • Novo Nordisk Investigational Site
    Boca Raton, Florida 33433, United States
  • Novo Nordisk Investigational Site
    Gainesville, Florida 32609, United States
  • Novo Nordisk Investigational Site
    Gainesville, Florida 32653, United States
  • Novo Nordisk Investigational Site
    Hialeah, Florida 33012, United States
  • Novo Nordisk Investigational Site
    Miami, Florida 33173, United States
  • Novo Nordisk Investigational Site
    Miami, Florida 33183, United States
  • Novo Nordisk Investigational Site
    Pembroke Pines, Florida 33026, United States
  • Novo Nordisk Investigational Site
    Ponte Vedra, Florida 32081, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30342, United States
  • Novo Nordisk Investigational Site
    Marietta, Georgia 30067, United States
  • Novo Nordisk Investigational Site
    Evanston, Illinois 60201-2477, United States
  • Novo Nordisk Investigational Site
    Evansville, Indiana 47714, United States
  • Novo Nordisk Investigational Site
    Newton, Kansas 67114, United States
  • Novo Nordisk Investigational Site
    Louisville, Kentucky 40206, United States
  • Novo Nordisk Investigational Site
    Madisonville, Kentucky 42431, United States
  • Novo Nordisk Investigational Site
    Marrero, Louisiana 70072, United States
  • Novo Nordisk Investigational Site
    Slidell, Louisiana 70458, United States
  • Novo Nordisk Investigational Site
    Slidell, Louisiana 70461-4231, United States
  • Novo Nordisk Investigational Site
    Rockville, Maryland 20852, United States
  • Novo Nordisk Investigational Site
    Boston, Massachusetts 02215, United States
  • Novo Nordisk Investigational Site
    Buckley, Michigan 49620, United States
  • Novo Nordisk Investigational Site
    Belzoni, Mississippi 39038, United States
  • Novo Nordisk Investigational Site
    Bridgeton, Missouri 63044, United States
  • Novo Nordisk Investigational Site
    Kalispell, Montana 59901, United States
  • Novo Nordisk Investigational Site
    Elkhorn, Nebraska 68022, United States
  • Novo Nordisk Investigational Site
    Las Vegas, Nevada 89103, United States
  • Novo Nordisk Investigational Site
    Lawrenceville, New Jersey 08648, United States
  • Novo Nordisk Investigational Site
    Hopewell Junction, New York 12553, United States
  • Novo Nordisk Investigational Site
    Statesville, North Carolina 28625, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45219, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45227, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45255, United States
  • Novo Nordisk Investigational Site
    Delaware, Ohio 43015, United States
  • Novo Nordisk Investigational Site
    Dublin, Ohio 43016, United States
  • Novo Nordisk Investigational Site
    Kettering, Ohio 45429, United States
  • Novo Nordisk Investigational Site
    Mason, Ohio 45040-6815, United States
  • Novo Nordisk Investigational Site
    Oklahoma City, Oklahoma 73112, United States
  • Novo Nordisk Investigational Site
    Corvallis, Oregon 97330-3737, United States
  • Novo Nordisk Investigational Site
    Downingtown, Pennsylvania 19335-2620, United States
  • Novo Nordisk Investigational Site
    Media, Pennsylvania 19063, United States
  • Novo Nordisk Investigational Site
    Smithfield, Pennsylvania 15478, United States
  • Novo Nordisk Investigational Site
    Uniontown, Pennsylvania 15401, United States
  • Novo Nordisk Investigational Site
    Charleston, South Carolina 29412, United States
  • Novo Nordisk Investigational Site
    Hodges, South Carolina 29653, United States
  • Novo Nordisk Investigational Site
    Indian Land, South Carolina 29707, United States
  • Novo Nordisk Investigational Site
    Mount Pleasant, South Carolina 29464, United States
  • Novo Nordisk Investigational Site
    Bristol, Tennessee 37620-7352, United States
  • Novo Nordisk Investigational Site
    Chattanooga, Tennessee 37404, United States
  • Novo Nordisk Investigational Site
    Johnson City, Tennessee 37604, United States
  • Novo Nordisk Investigational Site
    Kingsport, Tennessee 37660, United States
  • Novo Nordisk Investigational Site
    Memphis, Tennessee 38119-4806, United States
  • Novo Nordisk Investigational Site
    Nashville, Tennessee 37203, United States
  • Novo Nordisk Investigational Site
    Arlington, Texas 76012-4637, United States
  • Novo Nordisk Investigational Site
    Austin, Texas 78705, United States
  • Novo Nordisk Investigational Site
    Carrollton, Texas 75010, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75220, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75230, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75251, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75390-9302, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77008, United States
  • Novo Nordisk Investigational Site
    Missouri City, Texas 77459, United States
  • Novo Nordisk Investigational Site
    New Braunfels, Texas 78130, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78230, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78258, United States
  • Novo Nordisk Investigational Site
    Sugar Land, Texas 77479, United States
  • Novo Nordisk Investigational Site
    Waco, Texas 76710, United States
  • Novo Nordisk Investigational Site
    Bountiful, Utah 84010, United States
  • Novo Nordisk Investigational Site
    Clinton, Utah 84015, United States
  • Novo Nordisk Investigational Site
    Riverton, Utah 84065, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23219, United States
  • Novo Nordisk Investigational Site
    Virginia Beach, Virginia 23454, United States
  • Novo Nordisk Investigational Site
    Winchester, Virginia 22601, United States
  • Novo Nordisk Investigational Site
    Renton, Washington 98057, United States
  • Novo Nordisk Investigational Site
    Spokane, Washington 99216-1557, United States
  • Novo Nordisk Investigational Site
    Graz, 8010, Austria
  • Novo Nordisk Investigational Site
    Saint Stefan, 8511, Austria
  • Novo Nordisk Investigational Site
    Wien, 1130, Austria
  • Novo Nordisk Investigational Site
    Coquitlam, British Columbia V3K 3P4, Canada
  • Novo Nordisk Investigational Site
    Moncton, New Brunswick E1G 1A7, Canada
  • Novo Nordisk Investigational Site
    Hamilton, Ontario L8K 3P3, Canada
  • Novo Nordisk Investigational Site
    Hamilton, Ontario L8M 1K7, Canada
  • Novo Nordisk Investigational Site
    Sarnia, Ontario N7T 4X3, Canada
  • Novo Nordisk Investigational Site
    Strathroy, Ontario N7G 1Y7, Canada
  • Novo Nordisk Investigational Site
    Laval, Quebec H7T 2P5, Canada
  • Novo Nordisk Investigational Site
    Pointe Claire, Quebec H9R 4S3, Canada
  • Novo Nordisk Investigational Site
    Benesov, 25601, Czechia
  • Novo Nordisk Investigational Site
    Brno, 602 00, Czechia
  • Novo Nordisk Investigational Site
    Liberec, 46001, Czechia
  • Novo Nordisk Investigational Site
    Nachod, 54701, Czechia
  • Novo Nordisk Investigational Site
    Plzeň, 301 00, Czechia

Showing the first 100 of 150 sites across 10 countries.

09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02461589
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 3, 2015
Start date
Sep 21, 2015
Primary completion
Oct 13, 2016
Completion
Oct 13, 2016
Results posted
Jan 23, 2018
Last update
Jul 31, 2019

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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