A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease

Phase 2

Completed

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

• Registration Number: NCT01680978
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Study Start: 2012-10
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aleglitazar	aleglitazar	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)	from baseline to Week 6

Secondary Outcome Measures

Name	Time	Method
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