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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: February 24, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Drug: liraglutide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:
  • Percentage of subjects with an adverse events [ Time Frame: after 12 weeks of treatment ]
  • Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ]
  • Change from baseline in ECG [ Time Frame: week 0, week 12 ]
  • Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ]
  • Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ]
  • Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ]
  • Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ]
  • Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ]
  • Change from baseline in calcitonin [ Time Frame: week 0, week 12 ]
  • Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ]

Enrollment: 415
Actual Study Start Date: June 3, 2008
Study Completion Date: February 5, 2009
Primary Completion Date: February 5, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Name: NN9535
Experimental: B Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Name: NN9535
Experimental: C Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Name: NN9535
Experimental: D Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Name: NN9535
Experimental: E Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Name: NN9535
Experimental: F Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Name: NN9535
Placebo Comparator: G1 Drug: placebo
0.1 mg, once weekly, s.c. injection
Placebo Comparator: G2 Drug: placebo
0.2 mg, once weekly, s.c. injection
Placebo Comparator: G3 Drug: placebo
0.4 mg, once weekly, s.c. injection
Placebo Comparator: G4 Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Placebo Comparator: G5 Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
Placebo Comparator: G6 Drug: placebo
1.6 mg, once weekly, s.c. injection
Experimental: H Drug: liraglutide
1.2 mg with titration, once daily, s.c. injection
Experimental: I Drug: liraglutide
1.8 mg with titration, once daily, s.c. injection

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696657

  Show 77 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696657     History of Changes
Other Study ID Numbers: NN9535-1821
2007-003956-12 ( EudraCT Number )
Study First Received: June 11, 2008
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 16, 2017