A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Actos; Drug: aleglitazar

• Registration Number: NCT00461058
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-16
• Study First Submitted QC: 2007-04-16
• Study First Posted: 2007-04-17
• Study Start: 2007-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• adult patients, >=18 years of age;
• type 2 diabetes for >=1 month;
• drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications;
• HbA1c 6.5-10.0% at screening;
• symptomatic, stable NYHA class 2 heart failure at screening.

Exclusion Criteria

• type 1 diabetes;
• current or previous treatment with insulin;
• uncontrolled hypertension;
• NYHA class 1, 3 or 4 at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actos	Actos	-
Aleglitazar	aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.	26 week

Secondary Outcome Measures

Name	Time	Method
Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.	26 week
Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.	26 week