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

NCT01680978 | Completed Phase 2

• 1 other identifier: BC25445
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)

  from baseline to Week 6

Secondary Outcomes (2)

• Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)

  from baseline to Week 6

• Change in cardiac/hepatic triglyceride content assessed my MRS

  from baseline to Week 6

Study Arms (2)

Aleglitazar

EXPERIMENTAL

Drug: aleglitazar

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

aleglitazar DRUG

150 mcg orally daily, 6 weeks

Aleglitazar

placebo DRUG

orally daily, 6 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)