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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | 150 mcg orally daily |
| |
| placebo |
| 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 peroxisome proliferator activated receptor (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
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 New York Heart Association (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 |
|---|---|---|---|---|---|---|
| Chongqing | 400016 | China | ||||
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| Drug |
matching aleglitazar placebo orally daily |
|
| 26 weeks |
| Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [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 |
| Shanghai |
| 200003 |
| China |
| Shiyan | 442000 | China |
| Suzhou | 215004 | China |
| Hong Kong | Hong Kong |
| Alor Star | 05400 | Malaysia |
| Perak | 33400 | Malaysia |
| 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 |
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