A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DIABETES MELLITUS AND NO HISTORY OF CORONARY ARTERY DISEASE WHO ARE DRUG-NAÏVE OR TREATED WITH STABLE METFORMIN MONOTHERAPY

Hoffmann-La Roche0 sites18 target enrollmentOctober 2012

ConditionsDiabetes Mellitus Type 2

Interventionsplacebo aleglitazar

Drugsaleglitazar placebo

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 18
Primary Endpoint: Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

September 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, 40 to 70 years of age (inclusive) at screening
•Patients with Type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
•HbA1c \>/= 7 % and \</= 9% at screening
•Absence of history of coronary artery disease

Exclusion Criteria

•Diagnosis or history of Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
•Current treatment with fibrates, thiazolidinediones, or insulin
•Prior intolerance to thiazolidinediones and/or fibrates
•Clinically significant liver disease or impaired liver function
•Know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
•Symptomatic congestive heart failure classified as NYHA class II-IV
•Diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
•Contraindications to MRI, or inability to tolerate MRI scanning

Arms & Interventions

Placebo

Intervention: placebo

Aleglitazar

Intervention: aleglitazar

Outcomes

Primary Outcomes

Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)

Time Frame: from baseline to Week 6

Secondary Outcomes

Change in cardiac/hepatic triglyceride content assessed my MRS(from baseline to Week 6)
Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)(from baseline to Week 6)