A Study of Taspoglutide in Type 2 Diabetic Patients

Roche

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Placebo

Drug: taspoglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00811460

BP21844

2008-003582-97

Details and patient eligibility

About

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, 18-65 years of age;
type 2 diabetes mellitus;
treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion criteria

type 1 diabetes mellitus;
type 2 diabetes duration of <3 months;
treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
treatment with insulin for >7 days within 6 months prior to screening.