A Titration Study of a Glucagon-Like Peptide-1 (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 Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460941
• Other study ID #: BC20728
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2007
• Last updated: November 1, 2016
• Start date: April 2007
• Est. completion date: January 2008

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 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses 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 (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. 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: 133
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;

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

• HbA1c >=7.0% and <=9.5% at screening;

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

Exclusion Criteria:

• type 1 diabetes mellitus;

• clinically significant gastrointestinal disease;

• 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;

• previous exposure to GLP-1 or GLP-1 analogues.

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 20mg-30mg
sc weekly
• Taspoglutide 20mg-40mg
sc weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Mexico,  Peru,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients withdrawn because of gastrointestinal effects		Week 9	Yes
Secondary	Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.		Week 9	No