Phase 3
Completed N=77
Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
Source: ClinicalTrials.gov NCT02564211 ↗Enrolled (actual)
77
Serious AEs
6.5%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) — 77.9 Percentage of participants
◆ 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 to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.
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 Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) |
77.9 | — |
| PRIMARY Percentage of Participants Who Had Study Drug Discontinued Due to an AE |
5.2 | — |
| SECONDARY Change From Baseline in HbA1c |
-0.80 | — |
Eligibility Criteria
Inclusion Criteria
- Has Type 2 diabetes mellitus
- Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
- Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation
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, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
- Currently has a urinary tract infection or genital infection with subjective symptom
Data sourced from ClinicalTrials.gov (NCT02564211) 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.