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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680978
• Other study ID #: BC25445
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2012
• Last updated: November 1, 2016
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Drug:
• aleglitazar
150 mcg orally daily, 6 weeks
• placebo
orally daily, 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)		from baseline to Week 6	No
Secondary	Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)		from baseline to Week 6	No
Secondary	Change in cardiac/hepatic triglyceride content assessed my MRS		from baseline to Week 6	No