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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 415
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Experimental: B Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Experimental: C Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Experimental: D Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Experimental: E Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Experimental: F Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
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
Genders Eligible for Study:   Both
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

Locations
Bulgaria
Russe, Bulgaria, 7000
Finland
Turku, Finland, FI-20520
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro, 11000
France
MONTPELLIER cedex 5, France, 34295
Germany
Pohlheim, Germany, 35415
Hungary
Budapest, Hungary, 1041
India
Chennai, Tamil Nadu, India, 600086
Italy
Chieti Scalo, Italy, 66100
Spain
Almería, Spain, 04001
Switzerland
Genève 14, Switzerland, 1211
Turkey
Istanbul, Turkey, 34390
United Kingdom
Bexhill-on-Sea, United Kingdom, TN39 4SP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Christine B. Jensen, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00696657     History of Changes
Other Study ID Numbers: NN9535-1821, 2007-003956-12
Study First Received: June 11, 2008
Last Updated: October 30, 2013
Health Authority: Austria: Federal Ministry for Health and Women
Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Serbia: Medicines and Medical Devices Agency of Serbia
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Switzerland: Laws and standards
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014