| Trial ID: | L6635 |
| Source ID: | NCT01871428
|
| Associated Drug: |
Aleglitazar
|
| Title: |
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: aleglitazar|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 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
|
| Sponsor/Collaborators: |
Sponsor: Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
13
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-06
|
| Completion Date: |
2013-11
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-02
|
| Locations: |
Chongqing, 400016, China|Shanghai, 200003, China|Shiyan, 442000, China|Suzhou, 215004, China|Hong Kong, Hong Kong|Alor Setar, 05400, Malaysia|Perak, 33400, Malaysia
|
| URL: |
https://clinicaltrials.gov/show/NCT01871428
|
