A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423501
• Other study ID #: BC20688
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2007
• Last updated: November 1, 2016
• Start date: February 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-75 years of age;

• type 2 diabetes mellitus, with stable metformin treatment for >=3 months;

• stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

• type 1 diabetes mellitus;

• treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;

• use of weight-lowering medications in the last 3 months;

• uncontrolled hypertension.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
sc weekly
• taspoglutide
20mg sc weekly
• taspoglutide
10mg sc every 2 weeks
• taspoglutide
5mg sc weekly
• taspoglutide
10mg sc weekly
• taspoglutide
20mg sc every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Germany,  Guatemala,  Hong Kong,  Latvia,  Lithuania,  Mexico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbAlc		Week 8	No
Secondary	Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.		Week 8	No
Secondary	Changes in lipid profile		Week 8	No
Secondary	AEs, laboratory parameters, primary pharmacokinetic parameters		Throughout study	No