Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
1 other identifier
interventional
177
4 countries
39
Brief Summary
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes
Started Jan 2005
Shorter than P25 for phase_2 diabetes
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJanuary 25, 2017
January 1, 2017
9 months
September 8, 2005
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 14 weeks treatment
Secondary Outcomes (3)
Body weight after 14 weeks.
Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
Safety and tolerability
Interventions
Eligibility Criteria
You may qualify if:
- Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
- Diet treated subjects: 7.5% \< HbA1c \< 10%
- Single oral drug therapy subjects: 7.0% \< HbA1c \< 9.5%
- Body Mass Index (BMI): max 40 kg/m\^2
You may not qualify if:
- Subjects treated with thiazolidinediones or insulin
- Subjects with any serious medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (39)
Novo Nordisk Investigational Site
Aalborg, 9000, Denmark
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Novo Nordisk Investigational Site
Copenhagen, 2400, Denmark
Novo Nordisk Investigational Site
Hellerup, 2900, Denmark
Novo Nordisk Investigational Site
Hvidovre, 2650, Denmark
Novo Nordisk Investigational Site
Kolding, 6000, Denmark
Novo Nordisk Investigational Site
København S, 2300, Denmark
Novo Nordisk Investigational Site
Køge, 4600, Denmark
Novo Nordisk Investigational Site
Antibes, 06600, France
Novo Nordisk Investigational Site
Dax, 40107, France
Novo Nordisk Investigational Site
La Rochelle, 17019, France
Novo Nordisk Investigational Site
Marseille, 13009, France
Novo Nordisk Investigational Site
Montpellier, 34295, France
Novo Nordisk Investigational Site
Mougins, 06250, France
Novo Nordisk Investigational Site
Narbonne, 11108, France
Novo Nordisk Investigational Site
Nevers, 58033, France
Novo Nordisk Investigational Site
Nîmes, 30006, France
Novo Nordisk Investigational Site
Pessac, 33600, France
Novo Nordisk Investigational Site
Rennes, 35056, France
Novo Nordisk Investigational Site
Vénissieux, 69200, France
Novo Nordisk Investigational Site
's-Hertogenbosch, 5223 GV, Netherlands
Novo Nordisk Investigational Site
Amsterdam, 1105 AZ, Netherlands
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ, Netherlands
Novo Nordisk Investigational Site
Groningen, 9713 GZ, Netherlands
Novo Nordisk Investigational Site
Hengelo, 7555 DL, Netherlands
Novo Nordisk Investigational Site
Sliedrecht, 3361 XV, Netherlands
Novo Nordisk Investigational Site
The Hague, 2512 VA, Netherlands
Novo Nordisk Investigational Site
Banská Bystrica, 95717, Slovakia
Novo Nordisk Investigational Site
Bratislava, 811 08, Slovakia
Novo Nordisk Investigational Site
Bratislava, 81526, Slovakia
Novo Nordisk Investigational Site
Bratislava, 82102, Slovakia
Novo Nordisk Investigational Site
Bratislava, 831 01, Slovakia
Novo Nordisk Investigational Site
Košice, 040 01, Slovakia
Novo Nordisk Investigational Site
Košice, 04011, Slovakia
Novo Nordisk Investigational Site
Košice, 04190, Slovakia
Novo Nordisk Investigational Site
Lučenec, 98401, Slovakia
Novo Nordisk Investigational Site
Prešov, 080 01, Slovakia
Novo Nordisk Investigational Site
Šahy, 93601, Slovakia
Novo Nordisk Investigational Site
Žilina, 01001, Slovakia
Related Publications (5)
Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.
PMID: 18201212RESULTCourreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available.
PMID: 19183322RESULTVilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.
PMID: 17372153RESULTHorowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available.
PMID: 18435773RESULTJensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PMID: 25504028RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
January 25, 2017
Record last verified: 2017-01