A Study of a 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; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423501

BC20688

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

306 participants in 6 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

2

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

3

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

4

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

5

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

Drug: taspoglutide

6

Placebo Comparator group

Treatment:

Drug: Placebo