| Trial ID: | L5608 |
| Source ID: | NCT01871415
|
| Associated Drug: |
Aleglitazar
|
| Title: |
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: aleglitazar|DRUG: metformin|DRUG: placebo
|
| Outcome Measures: |
Primary: Change in HbA1c, from baseline to Week 26 | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-05
|
| Completion Date: |
2013-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
|
| Locations: |
Shanghai, 200003, China|ShenYang, 110004, China|Shiyan, 442000, China|Suzhou, 215004, China|Gyeonggi-do, 463-712, Korea, Republic of|Incheon, 405-760, Korea, Republic of|Seoul, 150-950, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01871415
|
