A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
NCT ID: NCT01871415
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE3
7 participants
INTERVENTIONAL
2013-05-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aleglitazar + metformin
aleglitazar
150 mcg orally daily
metformin
pre-existing background regimen and dose
Placebo + metformin
metformin
pre-existing background regimen and dose
placebo
matching aleglitazar placebo orally daily
Interventions
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aleglitazar
150 mcg orally daily
metformin
pre-existing background regimen and dose
placebo
matching aleglitazar placebo orally daily
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be \>/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label
* HbA1c \>/= 7% and \</= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</= 13.3 mmol/L (\</= 240 mg/dL) at pre-randomization visit
* Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
Exclusion Criteria
* Diagnosis or history of:
1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
* Any previous treatment with thiazolidinedione or with a dual PPAR agonist
* Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (\>= 1 month) statin therapy
* Prior intolerance to fibrate
* Treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening
* Triglycerides (fasting) \> 4.5 mmol/L (\> 400 mg/dL) at screening or within 4 weeks prior to screening
* Clinically apparent liver disease
* Anemia at or within 4 weeks prior to screening
* Inadequate renal function
* Symptomatic congestive heart failure NYHA Class II-IV at screening
* Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
* Known macular edema at screening or prior to screening visit
* Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
* Uncontrolled hypertension
* History of active substance abuse (including alcohol) within the past 2 years
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Shanghai, , China
Shenyang, , China
Shiyan, , China
Suzhou, , China
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Countries
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Other Identifiers
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YC28036
Identifier Type: -
Identifier Source: org_study_id