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This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 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+metformin | Drug | 150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hemoglobin HbA1c | From baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid profile | From baseline to week 26 | |
| Change from baseline in fasting plasma glucose | From baseline to week 26 | |
| Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chino | California | 91710 | United States | |||
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| placebo+metformin | Drug | Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose) |
|
| From baseline to week 26 |
| Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) | From baseline to week 26 |
| Change from baseline in homeostatic index of beta cell function (HOMA-BCF) | From baseline to week 26 |
| Safety: incidence of adverse events | 30 weeks (26 weeks treatment and 4 weeks follow-up) |
| Hawaiian Gardens |
| California |
| 90716 |
| United States |
| Los Angeles | California | 90057 | United States |
| Santa Ana | California | 92701 | United States |
| Thousand Oaks | California | 91360 | United States |
| West Hills | California | 91307 | United States |
| Kissimmee | Florida | 34741 | United States |
| Atlanta | Georgia | 30338 | United States |
| Chicago | Illinois | 60607 | United States |
| Avon | Indiana | 46123 | United States |
| Bethesda | Maryland | 20817 | United States |
| Springfield | Missouri | 65807 | United States |
| Toms River | New Jersey | 08753 | United States |
| Altoona | Pennsylvania | 16602 | United States |
| Beaver | Pennsylvania | 15009 | United States |
| Morrisville | Pennsylvania | 19067 | United States |
| Scranton | Pennsylvania | 18510 | United States |
| Tipton | Pennsylvania | 16684 | United States |
| Knoxville | Tennessee | 37919 | United States |
| Dallas | Texas | 75230 | United States |
| Richmond | Virginia | 23249 | United States |
| Spokane | Washington | 99202 | United States |
| Buenos Aires | 1056 | Argentina |
| Caba | C1428DCO | Argentina |
| Rosario | S2000CXP | Argentina |
| Cuernavaca | 62250 | Mexico |
| Culiacán | 80020 | Mexico |
| Guadalajara | 44650 | Mexico |
| Mexico City | 11650 | Mexico |
| Pachuca | 42060 | Mexico |
| Tampico | 89000 | Mexico |
| 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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