A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Roche

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: taspoglutide; Drug: metformin; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00755287

2008-001855-23

BC20965

Details and patient eligibility

About

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

Enrollment: 1,072 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-75 years of age;
• type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
• C-peptide (fasting) >=1.0ng/mL;
• HbA1c >=7.0% 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;
• 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: None (Open label)

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1,072 participants in 3 patient groups

insulin glargine

Active Comparator group

Description:

insulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment

Treatment:

Drug: insulin glargine

Drug: metformin

taspoglutide 10 mg

Experimental group

Description:

taspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: metformin

taspoglutide 10 mg/20 mg

Experimental group

Description:

taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment

Treatment:

Drug: taspoglutide

Drug: taspoglutide

Drug: metformin