A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

Roche

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: taspoglutide; Drug: placebo; Drug: pioglitazone; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744367

2008-001744-39

BC20963

Details and patient eligibility

About

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. 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 1-2 years, and the target sample size is 100-500 individuals.

Enrollment: 326 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years age;
• type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
• HbA1c >=7.0% and <=10.0% at screening;
• BMI >= 25 (>23 for Asians) and <=45 kg/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;
• clinically symptomatic gastrointestinal disease;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
• known hemoglobinopathy or chronic anemia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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326 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo in addition to continued stable metformin plus pioglitazone treatment. 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.

Treatment:

Drug: metformin

Drug: taspoglutide

Drug: placebo

Drug: pioglitazone

Drug: taspoglutide

Taspoglutide 10mg

Experimental group

Description:

Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment

Treatment:

Drug: metformin

Drug: taspoglutide

Drug: pioglitazone

Drug: taspoglutide

Taspoglutide 10mg/20mg

Experimental group

Description:

Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.

Treatment:

Drug: metformin

Drug: taspoglutide

Drug: pioglitazone

Drug: taspoglutide