Phase 3
Completed N=141
Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)
Source: ClinicalTrials.gov NCT02577016 ↗Enrolled (actual)
141
Serious AEs
2.1%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in HbA1c at Week 24 — -0.69; 0.14 Percent — p=<0.001
◆ Published Evidence
Emerging
4citations · ~1 / year
A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin.
Summary
This is a study to assess the safety and efficacy of the addition of sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on ipragliflozin, diet, and exercise therapy. The primary hypothesis of the study is that the addition of sitagliptin once daily compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline (Week 0) to Week 24.
Linked Publications
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A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 24 |
-0.69; 0.14 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
54.3; 63.4 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
2.9; 0.0 | — |
| SECONDARY Change From Baseline in 2-hr PMG at Week 24 |
-39.0; 3.4 | <0.001 sig |
| SECONDARY Change From Baseline in Glucose Total Area Under the Plasma Concentration Curve From Hour 0 to Hour 2 (AUC0-2hr) After Meal at Week 24 |
-65.7; 1.3 | <0.001 sig |
| SECONDARY Change From Baseline in FPG at Week 24 |
-11.8; -0.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Inadequate glycemic control on diet/exercise therapy and ipragliflozin 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, sitagliptin within 8 weeks prior to study participation.
- Currently has a urinary tract infection or genital infection with subjective symptom
Data sourced from ClinicalTrials.gov (NCT02577016) 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.