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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

NCT ID: NCT01680978

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aleglitazar

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

150 mcg orally daily, 6 weeks

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

orally daily, 6 weeks

Interventions

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aleglitazar

150 mcg orally daily, 6 weeks

Intervention Type DRUG

placebo

orally daily, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BC25445

Identifier Type: -

Identifier Source: org_study_id