A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

Hoffmann-La Roche305 enrolled

Overview

This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

305

Conditions

Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks; * HbA1c \>=6.5% and \<=9.5% at screening; * BMI \>=30 and \<=50 kg/m2 at screening; * stable weight +/-5% for at least 12 weeks prior to screening. Exclusion Criteria: * history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; * evidence of clinically significant diabetic complications; * myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Locations (71)

Unnamed facility

Bermuda Dunes, California, United States

Unnamed facility

La Jolla, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Mission Viejo, California, United States

Unnamed facility

Brooksville, Florida, United States

Unnamed facility

Outcomes

Primary Outcomes

Absolute change from baseline in HbA1c

Time frame: 24 weeks

Secondary Outcomes

Change from baseline in body weight;% of patients achieving >=5% weight loss

Time frame: 24 weeks

% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function

Time frame: 24 weeks

Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n

Time frame: At planned clinic visits, for 12 months