Clinical Trial Details
| Trial ID: | L4922 |
| Source ID: | NCT01691755 |
| Associated Drug: | Placebo |
| Title: | A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type 2 |
| Interventions: | DRUG: Placebo|DRUG: aleglitazar |
| Outcome Measures: | Primary: Change from baseline in hemoglobin HbA1c, From baseline to week 26 | Secondary: 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 A1c (HbAc1) <7.0% (<6.5%), 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) |
| Sponsor/Collaborators: | Sponsor: Hoffmann-La Roche |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 196 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-11 |
| Completion Date: | 2013-09 |
| Results First Posted: | |
| Last Update Posted: | 2016-08-11 |
| Locations: | Chino, California, 91710, United States|Los Angeles, California, 90057, United States|Santa Ana, California, 92701, United States|Thousand Oaks, California, 91360, United States|Upland, California, 91786, United States|West Hills, California, 91307, United States|Boynton Beach, Florida, 33472, United States|Cooper City, Florida, 33024, United States|Coral Gables, Florida, 33134, United States|Jacksonville, Florida, 32216, United States|Kissimmee, Florida, 34741, United States|Atlanta, Georgia, 30338, United States|Chicago, Illinois, 60607, United States|Avon, Indiana, 46123, United States|St Peters, Missouri, 63376, United States|Greensboro, North Carolina, 27408, United States|Portland, Oregon, 97239, United States|Altoona, Pennsylvania, 16602, United States|Scranton, Pennsylvania, 18510, United States|Tipton, Pennsylvania, 16684, United States|Greer, South Carolina, 29651, United States|Knoxville, Tennessee, 37919, United States|Spokane, Washington, 99202, United States|Aguascaliente, 20230, Mexico|Cuernavaca, 62250, Mexico|Culiacan, 80020, Mexico|Durango, 34000, Mexico|Durango, 34080, Mexico|Guadalajara, 44600, Mexico|Mexico City, 11650, Mexico|Monterrey, 64460, Mexico|Pachuca, 42090, Mexico|Queretaro, 76000, Mexico|Tampico, 89000, Mexico |
| URL: | https://clinicaltrials.gov/show/NCT01691755 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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