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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: aleglitazar; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01680978

BC25445

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups, including a placebo group

Aleglitazar

Experimental group

Treatment:

Drug: aleglitazar

Placebo

Placebo Comparator group

Treatment:

Drug: placebo