Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
aleglitazar · 18 trials · 3 indications
AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.
Cmax was obtained directly from the concentration-time data.
| Arm | Type | Description |
|---|---|---|
| Aleglitazar | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Aleglitazar + metformin | EXPERIMENTAL | - |
| Placebo + metformin | ACTIVE_COMPARATOR | - |
| pioglitazone | ACTIVE_COMPARATOR | - |
| aleglitazar / digoxin | EXPERIMENTAL | - |
| Treatment | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Mild impairment | EXPERIMENTAL | - |
| Moderate impairment | EXPERIMENTAL | - |
| Normal HF | EXPERIMENTAL | - |
| 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 |
| digoxin | DRUG | Single dose of digoxin |
| rifampicin | DRUG | Single dose in Periods 1 and 2; multiple doses in Period 3 |
| Microgynon® | DRUG | Multiple oral doses |
| lisinopril | DRUG | 20 mg orally daily, 6 weeks (Day 1 to Day 43) |
| aspirin | DRUG | repeated daily doses |
| ibuprofen | DRUG | repeated daily doses |
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 is an investigational small molecule being developed for cardiovascular disease and type 2 diabetes mellitus. It has been studied in healthy volunteers for drug interaction and pharmacokinetic trials. The drug is in Phase 3 clinical development, though all listed trials have been completed.
Aleglitazar is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has conducted clinical trials of the drug across multiple countries, including the United States, United Kingdom, China, and others.
Aleglitazar is in Phase 3 clinical development. It is an investigational drug, not approved by regulatory authorities. All ten clinical trials listed for the drug have been completed, with no active trials currently ongoing.
Aleglitazar has been studied in ten clinical trials with a total enrollment of 8,271 participants. Examples include NCT01188304, a Phase 1 study of aleglitazar with aspirin in healthy volunteers in the United States, and NCT01615354, a Phase 1 study with oral contraceptives in healthy female volunteers in the United Kingdom.
Yes, aleglitazar has been studied in randomized, double-blind, placebo-controlled clinical trials. The control type used in these trials was placebo, and the studies were designed to be double-blind, meaning neither participants nor researchers knew who received the active drug.
Aleglitazar is a small molecule therapeutic used in the metabolic therapeutic area. It is being investigated for cardiovascular disease and type 2 diabetes mellitus. The drug has been tested in healthy volunteers as well as in patients with these conditions.