A Study of Aleglitazar in Patients With Type 2 Diabetes

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Actos; Drug: aleglitazar; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388518

BM17864

Details and patient eligibility

About

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 332 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, diagnosed >=1 month of screening;
• either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
• HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion criteria

• type 1 diabetes;
• currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
• clinically significant cardiovascular disease;
• Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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332 participants in 6 patient groups, including a placebo group

Actos

Active Comparator group

Treatment:

Drug: Actos

Aleglitazar 1

Experimental group

Treatment:

Drug: aleglitazar

Aleglitazar 2

Experimental group

Treatment:

Drug: aleglitazar

Aleglitazar 3

Experimental group

Treatment:

Drug: aleglitazar

Aleglitazar 4

Experimental group

Treatment:

Drug: aleglitazar

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo