Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
aleglitazar · 14 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Aleglitazar | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Aleglitazar + metformin | EXPERIMENTAL | - |
| Placebo + metformin | ACTIVE_COMPARATOR | - |
| pioglitazone | ACTIVE_COMPARATOR | - |
| Actos | ACTIVE_COMPARATOR | - |
| Aleglitazar 1 | EXPERIMENTAL | - |
| Aleglitazar 2 | EXPERIMENTAL | - |
| Aleglitazar 3 | EXPERIMENTAL | - |
| Aleglitazar 4 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| aleglitazar | DRUG | 150 mcg orally daily |
| placebo | DRUG | matching aleglitazar placebo orally daily |
| metformin | DRUG | pre-existing background regimen and dose |
| 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) |
| 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) |
| pioglitazone | DRUG | Pioglitazone 45 mg po daily for 52 weeks |
| Actos | DRUG | 45mg po daily |
| lisinopril | DRUG | 20 mg orally daily, 6 weeks (Day 1 to Day 43) |
Inclusion Criteria: * Adult patient, \>/= 18 years of age * Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening * Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time in the pa...
Aleglitazar was developed for the treatment of type 2 diabetes mellitus and for reducing cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. It was studied both as monotherapy in drug-naive patients and in combination with metformin in patients inadequately controlled on metformin alone.
Aleglitazar targets PPARA and PPARG, acting as an agonist at both receptors. This dual agonist activity was designed to address glucose control and lipid parameters in type 2 diabetes. The compound is a small molecule and is catalogued in ChEMBL under the identifier CHEMBL519504.
Aleglitazar was developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. Roche sponsored the clinical trial program for the drug across type 2 diabetes and cardiovascular risk indications.
Aleglitazar reached Phase 3 clinical development. Across its program, 13 trials were conducted, all of which are completed, and none are currently active. The studies enrolled a total of 8,793 participants and included randomized, double-blind, placebo-controlled designs.
Aleglitazar was evaluated in completed trials including NCT01715818, a Phase 3 study of cardiovascular risk reduction in patients with stable cardiovascular disease and glucose abnormalities, NCT01871428, a Phase 3 monotherapy study in drug-naive type 2 diabetes patients, and NCT01871415, a Phase 3 study combining aleglitazar with metformin.