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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02577003 | Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843) | PHASE3 | COMPLETED | 143 | — | — | Nov 9, 2015 | Nov 25, 2016 | Sep 4, 2018 | - | — |
| NCT02564211 | Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849) | PHASE3 | COMPLETED | 77 | — | — | Oct 26, 2015 | Mar 7, 2017 | Sep 4, 2018 | - | — |
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.
The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.
| Arm | Type | Description |
|---|---|---|
| Ipragliflozin + Sitagliptin | EXPERIMENTAL | Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| Placebo + Sitagliptin | ACTIVE_COMPARATOR | Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise. |
| Ipragliflozin | EXPERIMENTAL | Ipragliflozin one 50 mg tablet co-administered with one 50 mg sitagliptin once daily (QD) for 52 weeks in addition to diet and exercise therapy. |
| Name | Type | Description |
|---|---|---|
| Ipragliflozin | DRUG | 50 mg tablet administered orally |
| Placebo | DRUG | Placebo to ipragliflozin tablet administered orally |
| Sitagliptin | DRUG | Background medication; 50 mg tablet administered orally |
Inclusion Criteria: * Type 2 diabetes mellitus * Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy * HbA1c ≥7.0% and ≤10.0% before study start Exclusion Criteria: * History of Type 1 diabetes mellitus or a history of ketoacidosis * History of any of the following me...