A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

Hoffmann-La Roche373 enrolled

Overview

This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

373

Conditions

Diabetes Mellitus Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients, 18-80 years of age; * drug naive patients with type 2 diabetes uncontrolled with diet and exercise; * tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies; * C-peptide (fasting) \>=1.0ng/mL * HbA1c \>=6.5% and \<=10.0% at screening; * BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening. Exclusion Criteria: * history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months; * evidence of clinically significant diabetic complications; * symptomatic poorly controlled diabetes; * myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months; * known hemoglobinopathy or chronic anemia.

Locations (58)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Santa Ana, California, United States

Unnamed facility

Avon, Indiana, United States

Unnamed facility

Pahrump, Nevada, United States

Unnamed facility

Outcomes

Primary Outcomes

Absolute change from baseline in HbA1c

Time frame: 24 weeks

Secondary Outcomes

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

Time frame: Throughout study

Change from baseline in fasting plasma glucose; change from baseline in body weight.

Time frame: 24 weeks

Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.

Time frame: 24 weeks