Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01555164 | A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone | PHASE3 | COMPLETED | 442 | — | — | Jun 1, 2012 | Oct 1, 2013 | Sep 23, 2014 | 146 | United States, Canada +9 |
| NCT01494987 | Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 431 | — | — | Jan 1, 2012 | Aug 1, 2013 | Nov 18, 2014 | 140 | United States, Czechia +10 |
| NCT01472185 | Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 465 | — | — | Nov 1, 2011 | Oct 1, 2013 | Oct 24, 2014 | 159 | United States, Czechia +8 |
| NCT01843127 | A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes. | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2013 | Sep 1, 2013 | Mar 31, 2014 | 3 | United States |
| NCT01546558 | Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg | PHASE1 | COMPLETED | 25 | — | — | Feb 1, 2012 | Mar 1, 2012 | Jul 11, 2012 | 1 | United States |
| NCT01546597 | Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2012 | Mar 1, 2012 | Jul 11, 2012 | 1 | United States |
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
| Arm | Type | Description |
|---|---|---|
| Ranolazine+metformin | EXPERIMENTAL | Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening). Treatment Period: Participants will receive ranolazine 500 mg + metformin 500 mg + placebo to match metformin twice daily on Days 1 through 7, followed by ranolazine 1000 mg + metformin 500 mg + placebo to match metformin twice daily from Day 8 through Week 24. Participants are required to maintain their diet and exercise regimen. |
| Placebo+metformin | PLACEBO_COMPARATOR | Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening). Treatment Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily through Week 24. Participants are required to maintain their diet and exercise regimen. |
| Ranolazine+glimepiride | EXPERIMENTAL | Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen. |
| Placebo+glimepiride | PLACEBO_COMPARATOR | Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen. |
| Placebo | PLACEBO_COMPARATOR | Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen. |
| Ranolazine | EXPERIMENTAL | Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days. Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks. Participants were required to maintain their diet and exercise regimen. |
| Placebo, Ranolazine, Exenatide | ACTIVE_COMPARATOR | - |
| Ranolazine, Placebo, Exenatide | ACTIVE_COMPARATOR | - |
| Metformin, Ranolazine | EXPERIMENTAL | Single cohort, 2-period study: * Period 1, metformin 1000 mg bid on Days 1-5 * Period 2, metformin 1000 mg bid + ranolazine 500 mg bid on Days 6-10 |
| Name | Type | Description |
|---|---|---|
| Ranolazine | DRUG | Ranolazine tablet(s) administered orally |
| Placebo to match ranolazine | DRUG | Placebo to match ranolazine for the duration of the study |
| Metformin | DRUG | Metformin tablet(s) administered orally once daily |
| Placebo to match metformin | DRUG | Placebo to match metformin for the duration of the study |
| Diet | BEHAVIORAL | Participants are instructed to continue the diet regimen prescribed by their physician. |
| Exercise | BEHAVIORAL | Participants are instructed to continue the exercise regimen prescribed by their physician. |
| Placebo | DRUG | Placebo to match ranolazine for the duration of the study |
| Glimepiride | DRUG | Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily. |
| Exenatide | DRUG | - |
Inclusion Criteria: * Documented history of T2DM * Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening * Body mass index (BMI) 25 to 45 kg/m\^2, inclusive, at Screening * HbA1c within specified ranges at Screening ...