A Study of Taspoglutide in Type 2 Diabetic Patients

Hoffmann-La Roche18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incremental area under insulin concentration time curve relative to basal insulin concentration

Time frame: First 10 minutes after glucose bolus

Secondary Outcomes

Incremental area under insulin concentration time curve relative to basal insulin concentration

Time frame: 10-120 minutes after glucose bolus

Adverse events, laboratory parameters

Time frame: Throughout study