A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

Roche

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: pioglitazone; Drug: taspoglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909597

BC21893

2009-009157-24

Details and patient eligibility

About

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Enrollment: 756 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 mellitus;
• treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
• HbA1c >=7.0% and <=10% at screening;
• stable weight +/-5% for >=12 weeks prior to screening.

Exclusion criteria

• type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
• clinically significant diabetic complications;
• clinically symptomatic gastrointestinal disease;
• >3 episodes of severe hypoglycemia within 6 months before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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756 participants in 3 patient groups

pioglitazone

Active Comparator group

Treatment:

Drug: pioglitazone

taspoglutide 10mg

Experimental group

Description:

taspoglutide 10mg sc weekly

Treatment:

Drug: taspoglutide

Drug: taspoglutide

taspoglutide 10mg/20mg

Experimental group

Description:

taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly

Treatment:

Drug: taspoglutide

Drug: taspoglutide