Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154401
• Other study ID #: NN2211-1571
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 24, 2017
• Start date: January 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Aalborg
Denmark	Novo Nordisk Investigational Site	Århus C
Denmark	Novo Nordisk Investigational Site	Hellerup
Denmark	Novo Nordisk Investigational Site	Hvidovre
Denmark	Novo Nordisk Investigational Site	København
Denmark	Novo Nordisk Investigational Site	København S
Denmark	Novo Nordisk Investigational Site	Køge
Denmark	Novo Nordisk Investigational Site	Kolding
France	Novo Nordisk Investigational Site	Antibes
France	Novo Nordisk Investigational Site	DAX
France	Novo Nordisk Investigational Site	LA ROCHELLE cedex
France	Novo Nordisk Investigational Site	Marseille
France	Novo Nordisk Investigational Site	Montpellier
France	Novo Nordisk Investigational Site	Mougins
France	Novo Nordisk Investigational Site	Narbonne
France	Novo Nordisk Investigational Site	NEVERS cedex
France	Novo Nordisk Investigational Site	Nimes
France	Novo Nordisk Investigational Site	Pessac
France	Novo Nordisk Investigational Site	Rennes
France	Novo Nordisk Investigational Site	Venissieux
Netherlands	Novo Nordisk Investigational Site	Amsterdam
Netherlands	Novo Nordisk Investigational Site	Apeldoorn
Netherlands	Novo Nordisk Investigational Site	Den Bosch
Netherlands	Novo Nordisk Investigational Site	Den Haag
Netherlands	Novo Nordisk Investigational Site	Groningen
Netherlands	Novo Nordisk Investigational Site	Hengelo
Netherlands	Novo Nordisk Investigational Site	Sliedrecht
Slovakia	Novo Nordisk Investigational Site	Banska Bystrica
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Kosice
Slovakia	Novo Nordisk Investigational Site	Kosice
Slovakia	Novo Nordisk Investigational Site	Kosice
Slovakia	Novo Nordisk Investigational Site	Lucenec
Slovakia	Novo Nordisk Investigational Site	Presov
Slovakia	Novo Nordisk Investigational Site	Sahy
Slovakia	Novo Nordisk Investigational Site	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  France,  Netherlands,  Slovakia, 

References & Publications (5)

Courrèges JP, Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Bugáñová 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 di — View Citation

Horowitz M, Vilsbøll 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. do — View 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- — View Citation

Vilsbøll T, Brock B, Perrild H, Levin K, Lervang HH, Kølendorf 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 — View Citation

Vilsbøll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courrèges JP, Verhoeven R, Bugánová I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 14 weeks treatment
Secondary	Body weight after 14 weeks.
Secondary	Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
Secondary	Safety and tolerability

External Links

•   Clinical Trials at Novo Nordisk