Clinical trial NCT00154401: Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Subjects treated with thiazolidinediones or insulin
* Subjects with any serious medical conditions

Primary outcomes:
measure: HbA1c
timeFrame: after 14 weeks treatment
Secondary outcomes:
measure: Body weight after 14 weeks.
measure: Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
measure: Safety and tolerability
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hellerup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
city: Kolding
country: Denmark
facility: Novo Nordisk Investigational Site
city: København S
country: Denmark
facility: Novo Nordisk Investigational Site
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Antibes
country: France
facility: Novo Nordisk Investigational Site
city: DAX
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Marseille
country: France
facility: Novo Nordisk Investigational Site
city: Montpellier
country: France
facility: Novo Nordisk Investigational Site
city: Mougins
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: Nimes
country: France
facility: Novo Nordisk Investigational Site
city: Pessac
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Bosch
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hengelo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Sliedrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Lucenec
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Presov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Sahy
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Zilina
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Courreges 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.
citation: Vilsboll 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.
citation: Horowitz 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.
citation: Jensen 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.