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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01680978
First received: September 4, 2012
Last updated: April 7, 2014
Last verified: April 2014

September 4, 2012
April 7, 2014
October 2012
September 2013   (final data collection date for primary outcome measure)
Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS) [ Time Frame: from baseline to Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01680978 on ClinicalTrials.gov Archive Site
  • Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI) [ Time Frame: from baseline to Week 6 ] [ Designated as safety issue: No ]
  • Change in cardiac/hepatic triglyceride content assessed my MRS [ Time Frame: from baseline to Week 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Diabetes Mellitus, Type 2
  • Drug: aleglitazar
    150 mcg orally daily, 6 weeks
  • Drug: placebo
    orally daily, 6 weeks
  • Experimental: Aleglitazar
    Intervention: Drug: aleglitazar
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01680978
BC25445
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP