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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar + metformin | Experimental |
| |
| Placebo + metformin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | 150 mcg orally daily |
| |
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | from baseline to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipids | from baseline to Week 26 | |
| Change in fasting plasma glucose (FPG) | from baseline to Week 26 | |
| Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
Diagnosis or history of:
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai | 200003 | China | ||||
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| Drug |
pre-existing background regimen and dose |
|
| placebo | Drug | matching aleglitazar placebo orally daily |
|
| 26 weeks |
| Change in homeostatic index of insulin sensitivity (by HOMA-IS) | from baseline to Week 26 |
| Change in homeostatic index of beta cell function (by HOMA-BFC) | from baseline to Week 26 |
| Change in markers of insulin sensitivity/cardiovascular risk | from baseline to Week 26 |
| Safety: Incidence of adverse events | approximately 30 weeks |
| Shenyang |
| 110004 |
| China |
| Shiyan | 442000 | China |
| Suzhou | 215004 | China |
| Gyeonggi-do | 463-712 | South Korea |
| Incheon | 405-760 | South Korea |
| Seoul | 150-950 | South Korea |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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