A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Taspoglutide 20mg; Drug: Taspoglutide 20mg-40mg; Drug: Taspoglutide 20mg-30mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460941

BC20728

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

sc weekly

Treatment:

Drug: Placebo

Taspoglutide 20mg

Experimental group

Description:

sc weekly

Treatment:

Drug: Taspoglutide 20mg

Taspoglutide 20mg-30mg

Experimental group

Description:

sc weekly

Treatment:

Drug: Taspoglutide 20mg-30mg

Taspoglutide 20mg-40mg

Experimental group

Description:

sc weekly

Treatment:

Drug: Taspoglutide 20mg-40mg