A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

August 1, 2019 updated by: Novo Nordisk A/S

Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

415

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Gratwein, Austria, 8112
        • Novo Nordisk Investigational Site
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Innsbruck, Austria, 6020
        • Novo Nordisk Investigational Site
      • Mödling, Austria, 2340
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1130
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1010
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Novo Nordisk Investigational Site
      • Russe, Bulgaria, 7000
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1233
        • Novo Nordisk Investigational Site
      • Varna, Bulgaria, 9010
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00270
        • Novo Nordisk Investigational Site
      • Imatra, Finland, FI-55120
        • Novo Nordisk Investigational Site
      • Mikkeli, Finland, FI-50100
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90029
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33101
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro, 11000
        • Novo Nordisk Investigational Site
  • France
      • Dommartin Les Toul, France, 54201
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • MONTPELLIER cedex 5, France, 34295
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35037
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1041
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Gyula, Hungary, 5700
        • Novo Nordisk Investigational Site
      • Pecs, Hungary, 7631
        • Novo Nordisk Investigational Site
      • Szekszárd, Hungary, 7100
        • Novo Nordisk Investigational Site
  • India
      • Chennai, India, 600008
        • Novo Nordisk Investigational Site
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
  • Italy
      • Catanzaro, Italy, 88100
        • Novo Nordisk Investigational Site
      • Chieti, Italy, 66100
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50141
        • Novo Nordisk Investigational Site
      • Milano (MI), Italy, 20132
        • Novo Nordisk Investigational Site
      • Napoli, Italy, 80131
        • Novo Nordisk Investigational Site
      • Perugia, Italy, 06126
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Gijón, Spain, 33206
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28040
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28007
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novo Nordisk Investigational Site
      • Genève 14, Switzerland, 1211
        • Novo Nordisk Investigational Site
      • Lausanne, Switzerland, 1011
        • Novo Nordisk Investigational Site
      • St. Gallen, Switzerland, 9007
        • Novo Nordisk Investigational Site
  • Turkey
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34390
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34400
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Addlestone, United Kingdom, KT15 2BH
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA2 1NH
        • Novo Nordisk Investigational Site
      • Bexhill-on-Sea, United Kingdom, TN39 4SP
        • Novo Nordisk Investigational Site
      • Bradford, United Kingdom, BD9 6RJ
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2RW
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3UJ
        • Novo Nordisk Investigational Site
      • Llanelli, United Kingdom, SA14 8QF
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Trowbridge, United Kingdom, BA14 8QA
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
  • Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
  • HbA1c: 7.0-10.0 % (both inclusive)
  • Body weight between 60 kg and 110 kg

Exclusion Criteria:

  • Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
  • Impaired liver or kidney function
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness
  • Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
EXPERIMENTAL: A
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
EXPERIMENTAL: E
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
EXPERIMENTAL: C
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
EXPERIMENTAL: D
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
EXPERIMENTAL: I
Drug: liraglutide
1.2 mg with titration, once daily, s.c. injection
Drug: liraglutide
1.8 mg with titration, once daily, s.c. injection
EXPERIMENTAL: F
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Names:
  • NN9535
PLACEBO_COMPARATOR: G1
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
PLACEBO_COMPARATOR: G2
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
PLACEBO_COMPARATOR: G3
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
PLACEBO_COMPARATOR: G4
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
PLACEBO_COMPARATOR: G5
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
PLACEBO_COMPARATOR: G6
Drug: placebo
0.1 mg, once weekly, s.c. injection
Drug: placebo
0.2 mg, once weekly, s.c. injection
Drug: placebo
0.4 mg, once weekly, s.c. injection
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Drug: placebo
1.6 mg, once weekly, s.c. injection
EXPERIMENTAL: H
Drug: liraglutide
1.2 mg with titration, once daily, s.c. injection
Drug: liraglutide
1.8 mg with titration, once daily, s.c. injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: After 12 weeks of treatment.
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
After 12 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With an Adverse Events
Time Frame: After 12 weeks of treatment.
The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
After 12 weeks of treatment.
Percentage of Subjects With Hypoglycaemic Episode
Time Frame: After 12 weeks of treatment
The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was <3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was >=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.
After 12 weeks of treatment
Change From Baseline in ECG
Time Frame: Week 0, week 12.
A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as "week -2, week 12". Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant [NCS] or abnormal clinically significant [CS]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).
Week 0, week 12.
Change From Baseline in Vital Signs (Pulse)
Time Frame: Week 0, week 12
Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Vital Signs (Blood Pressure; SBP)
Time Frame: Week 0, week 12
Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Vital Signs (Blood Pressure; DBP)
Time Frame: Week 0, week 12
Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
Time Frame: Week 0, week 12
Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
Time Frame: Week 0, week 12
Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
Time Frame: Week 0, week 12
Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
Time Frame: Week 0, week 12
Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
Time Frame: Week 0, week 12
Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
Time Frame: Week 0, week 12
Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
Time Frame: Week 0, week 12
Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
Time Frame: Week 0, week 12
Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
Time Frame: Week 0, week 12
Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
Time Frame: Week 0, week 12
Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
Time Frame: Week 0, week 12.
Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
Time Frame: Week 0, week 12.
Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
Time Frame: Week 0, week 12.
Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
Time Frame: Week 0, week 12.
Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
Time Frame: Week 0, week 12.
Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
Time Frame: Week 0, week 12.
Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
Time Frame: Week 0, week 12.
Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
Time Frame: Week 0, week 12.
Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
Time Frame: Week 0, week 12.
Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
Time Frame: Week 0, week 12.
Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
Time Frame: Week 0, week 12.
Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Time Frame: Week 0, week 12
Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Time Frame: Week 0, week 12
Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Time Frame: Week 0, week 12
Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Time Frame: Week 0, week 12
Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, >=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Week 0, week 12
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Time Frame: Week 0, week 12
Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, >=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.
Week 0, week 12
Change From Baseline in Calcitonin
Time Frame: Week 0, week 12.
Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Week 0, week 12.
Percentage of Subjects Developing Anti-semaglutide Antibodies
Time Frame: After 12 weeks of treatment
Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.
After 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry B. (GCR, 1452), MD, PhD, Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2008

Primary Completion (ACTUAL)

February 5, 2009

Study Completion (ACTUAL)

February 5, 2009

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (ESTIMATE)

June 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-1821
  • 2007-003956-12 (EUDRACT_NUMBER)

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