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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 is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01680978
First received: September 4, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: aleglitazar
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 28
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aleglitazar Drug: aleglitazar
150 mcg orally daily, 6 weeks
Placebo Comparator: Placebo Drug: placebo
orally daily, 6 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680978

Contacts
Contact: Reference Study ID Number: BC25445 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United Kingdom
Recruiting
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01680978     History of Changes
Other Study ID Numbers: BC25445
Study First Received: September 4, 2012
Last Updated: June 3, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013