Clinical Trial Details
| Trial ID: | L2899 |
| Source ID: | NCT01691989 |
| Associated Drug: | Aleglitazar |
| Title: | A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type 2 |
| Interventions: | DRUG: aleglitazar|DRUG: placebo |
| 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 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 markers of insulin sensitivity and cardiovascular risk, 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: | 197 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: |Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-12 |
| Completion Date: | 2013-09 |
| Results First Posted: | |
| Last Update Posted: | 2016-11-02 |
| Locations: | Chino, California, 91710, United States|Los Angeles, California, 90057, United States|San Diego, California, 92161, United States|Santa Ana, California, 92701, United States|Jacksonville, Florida, 32216, United States|Kissimmee, Florida, 34741, United States|St Petersburg, Florida, 33716, United States|Atlanta, Georgia, 30338, United States|Avon, Indiana, 46123, United States|Bethesda, Maryland, 20817, United States|Durham, North Carolina, 27713, United States|Morrisville, Pennsylvania, 19067, United States|Greer, South Carolina, 29651, United States|Dallas, Texas, 75230, United States|Richmond, Virginia, 23249, United States|Buenos Aires, 1056, Argentina|Caba, C1428DCO, Argentina|Rosario, S2000CXP, Argentina|Bogota, Colombia|Floridablanca, Colombia|Medellin-Antioquia, Colombia|Guatemala, 01010, Guatemala|Guatemala, 01014, Guatemala|Aguascaliente, 20230, Mexico|Celaya, 38000, Mexico|Guadalajara, 44600, Mexico|Guadalajara, 44650, Mexico|Queretaro, 76000, Mexico |
| URL: | https://clinicaltrials.gov/show/NCT01691989 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|