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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00696657
First received: June 11, 2008
Last updated: October 30, 2013
Last verified: October 2013

June 11, 2008
October 30, 2013
June 2008
February 2009   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in ECG [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in calcitonin [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: for the duration of the trial ] [ Designated as safety issue: Yes ]
  • Antibodies [ Time Frame: for the duration of the trial ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    0.1 mg, once weekly, s.c. injection
  • Drug: semaglutide
    0.2 mg, once weekly, s.c. injection
  • Drug: semaglutide
    0.4 mg, once weekly, s.c. injection
  • Drug: semaglutide
    0.8 mg, once weekly, s.c. injection
  • Drug: semaglutide
    0.8 mg with titration, once weekly, s.c. injection
  • Drug: semaglutide
    1.6 mg with titration, once weekly, s.c. injection
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
415
February 2009
February 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Finland,   Former Serbia and Montenegro,   France,   United Kingdom,   Hungary,   India,   Italy,   Spain,   Switzerland,   Turkey,   Bulgaria
 
NCT00696657
NN9535-1821, 2007-003956-12
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Christine B. Jensen, MD, PhD Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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