Phase 3
Completed N=143
Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)
Source: ClinicalTrials.gov NCT02577003 ↗Enrolled (actual)
143
Serious AEs
4.2%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in HbA1c at Week 24 — -0.84; -0.07 Percent — p=<0.001
◆ Published Evidence
Emerging
8citations · ~2 / year
Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin.
Summary
This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.
Linked Publications
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Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 24 |
-0.84; -0.07 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
50.7; 65.7 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
2.7; 5.7 | — |
| SECONDARY Change From Baseline in FPG at Week 24 |
-30.3; -2.1 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hr PMG at Week 24 |
-52.4; -3.8 | <0.001 sig |
| SECONDARY Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24 |
-86.9; -2.3 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 24 |
-2.4; -0.6 | <0.001 sig |
Eligibility Criteria
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 medications: thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation and sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
- Currently has a urinary tract infection or genital infection with subjective symptom
Data sourced from ClinicalTrials.gov (NCT02577003) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.