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

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ClinicalTrials.gov Identifier: NCT00696657
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

June 11, 2008
June 13, 2008
December 14, 2017
September 12, 2018
September 12, 2018
June 30, 2008
February 28, 2009   (Final data collection date for primary outcome measure)
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.
HbA1c [ Time Frame: for the duration of the trial ]
Complete list of historical versions of study NCT00696657 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • Safety [ Time Frame: for the duration of the trial ]
  • Antibodies [ Time Frame: for the duration of the trial ]
Not Provided
Not Provided
 
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    0.1 mg, once weekly, s.c. injection
    Other Name: NN9535
  • Drug: semaglutide
    0.2 mg, once weekly, s.c. injection
    Other Name: NN9535
  • Drug: semaglutide
    0.4 mg, once weekly, s.c. injection
    Other Name: NN9535
  • Drug: semaglutide
    0.8 mg, once weekly, s.c. injection
    Other Name: NN9535
  • Drug: semaglutide
    0.8 mg with titration, once weekly, s.c. injection
    Other Name: NN9535
  • Drug: semaglutide
    1.6 mg with titration, once weekly, s.c. injection
    Other Name: NN9535
  • 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
  • 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: A
    Intervention: Drug: semaglutide
  • Experimental: B
    Intervention: Drug: semaglutide
  • Experimental: C
    Intervention: Drug: semaglutide
  • Experimental: D
    Intervention: Drug: semaglutide
  • Experimental: E
    Intervention: Drug: semaglutide
  • Experimental: F
    Intervention: Drug: semaglutide
  • Placebo Comparator: G1
    Intervention: Drug: placebo
  • Placebo Comparator: G2
    Intervention: Drug: placebo
  • Placebo Comparator: G3
    Intervention: Drug: placebo
  • Placebo Comparator: G4
    Intervention: Drug: placebo
  • Placebo Comparator: G5
    Intervention: Drug: placebo
  • Placebo Comparator: G6
    Intervention: Drug: placebo
  • Experimental: H
    Intervention: Drug: liraglutide
  • Experimental: I
    Intervention: Drug: liraglutide
Nauck MA, Petrie JR, Sesti G, Mannucci E, Courrèges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
362
February 28, 2009
February 28, 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Finland,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   India,   Italy,   South Africa,   Spain,   Switzerland,   Turkey,   United Kingdom
Serbia
 
NCT00696657
NN9535-1821
2007-003956-12 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry B. (GCR, 1452), MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP