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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02068443 | Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy | PHASE3 | COMPLETED | 374 | — | — | Feb 1, 2014 | Feb 1, 2015 | Sep 28, 2023 | 27 | Japan |
| NCT00856284 | Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus | PHASE3 | COMPLETED | 2,639 | — | — | Mar 1, 2009 | Oct 1, 2012 | Dec 3, 2013 | 261 | United States, Argentina +30 |
| NCT00328627 | Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus. | PHASE3 | COMPLETED | 1,554 | — | — | May 1, 2006 | Mar 1, 2008 | Apr 4, 2013 | 90 | United States, Australia +17 |
| NCT01318135 | Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 576 | — | — | Jan 1, 2009 | Apr 1, 2010 | Aug 16, 2012 | - | — |
| NCT01318083 | Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 312 | — | — | Aug 1, 2008 | Apr 1, 2009 | Feb 3, 2012 | - | — |
| NCT01318109 | Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 288 | — | — | Aug 1, 2008 | Apr 1, 2009 | Feb 3, 2012 | - | — |
| NCT01318122 | Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 336 | — | — | May 1, 2008 | Aug 1, 2009 | Feb 3, 2012 | - | — |
| NCT01318070 | Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 339 | — | — | Nov 1, 2007 | Oct 1, 2008 | Feb 3, 2012 | - | — |
| NCT01263509 | Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 179 | — | — | Jun 1, 2007 | Oct 1, 2008 | Feb 3, 2012 | - | — |
| NCT01263496 | Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 438 | — | — | May 1, 2007 | Sep 1, 2008 | Feb 3, 2012 | - | — |
| NCT01263483 | Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan | PHASE2 | COMPLETED | 230 | — | — | Jan 1, 2007 | Apr 1, 2008 | Feb 3, 2012 | - | — |
The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.
The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone).
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
| Arm | Type | Description |
|---|---|---|
| Alogliptin Alone | ACTIVE_COMPARATOR | Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks. |
| Alogliptin + Metformin Hydrochloride QD | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, once, daily, after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks. |
| Alogliptin + Metformin Hydrochloride BID | ACTIVE_COMPARATOR | Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks. |
| Metformin + Alogliptin 12.5 mg | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. |
| Metformin + Alogliptin 25 mg | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. |
| Metformin + Glipizide | ACTIVE_COMPARATOR | Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals. |
| Placebo | PLACEBO_COMPARATOR | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 + Placebo | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 25 + Placebo | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks. |
| Placebo + Pioglitazone 15 | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 + Pioglitazone 15 | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 25 + Pioglitazone 15 | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks. |
| Placebo + Pioglitazone 30 | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 + Pioglitazone 30 | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 25 + Pioglitazone 30 | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| Placebo + Pioglitazone 45 | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 + Pioglitazone 45 | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 25 + Pioglitazone 45 | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID | ACTIVE_COMPARATOR | - |
| Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID | ACTIVE_COMPARATOR | - |
| Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and Glimepiride QD or BID | ACTIVE_COMPARATOR | - |
| Alogliptin 25 mg QD and Glimepiride QD or BID | ACTIVE_COMPARATOR | - |
| Glimepiride 1, 2, 3 or 4 mg QD or BID | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID | ACTIVE_COMPARATOR | - |
| Alogliptin 25mg QD and metformin 500mg BID or 750mg TID | ACTIVE_COMPARATOR | - |
| Metformin 500mg BID or 750mg TID | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD | ACTIVE_COMPARATOR | - |
| Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD | EXPERIMENTAL | - |
| Pioglitazone (15mg or 30mg ) QD | ACTIVE_COMPARATOR | - |
| Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | EXPERIMENTAL | - |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | EXPERIMENTAL | - |
| Alogliptin 6.25 mg QD | EXPERIMENTAL | - |
| Alogliptin 12.5 mg QD | EXPERIMENTAL | - |
| Alogliptin 25 mg QD | EXPERIMENTAL | - |
| Alogliptin 50 mg QD | EXPERIMENTAL | - |
| Voglibose 0.2-mg TID | ACTIVE_COMPARATOR | - |
| Voglibose 0.2 mg TID | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Alogliptin | DRUG | Alogliptin tablets |
| Metformin hydrochloride | DRUG | Metformin hydrochloride tablets |
| Metformin hydrochloride Placebo | DRUG | Metformin hydrochloride placebo-matching tablets |
| Metformin | DRUG | Metformin tablets |
| Glipizide | DRUG | Glipizide tablets |
| Alogliptin placebo | DRUG | Alogliptin placebo-matching tablets. |
| Pioglitazone | DRUG | Pioglitazone tablets. |
| Pioglitazone placebo | DRUG | Pioglitazone placebo-matching tablets. |
| Alogliptin and glimepiride | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. |
| Alogliptin and metformin | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. |
| Glimepiride | DRUG | Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks. |
| Alogliptin and pioglitazone | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. |
| Alogliptin and voglibose | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
| Voglibose | DRUG | Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. |
Inclusion Criteria: 1. Has a diagnosis of type 2 diabetes mellitus. 2. Has a hemoglobin A1c (HbA1c) (National glycohemoglobin standardization program \[NGSP\]) of ≥6.9% to \<10.5% at 8 weeks after the start of the screening period (Week -4). 3. Has an HbA1c (NGSP) difference between 4 weeks after t...