Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
This trial is active, not recruiting.
|Condition||type 2 diabetes mellitus|
|Sponsor||Merck Sharp & Dohme Corp.|
|Start date||October 2015|
|End date||March 2017|
|Trial size||75 participants|
|Trial identifier||NCT02564211, 0431J-849, 153083|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Ipragliflozin once daily for 52 weeks with sitagliptin, diet, and exercise.
Percentage of participants who experienced at least one adverse event (AE)
time frame: Up to 54 weeks
Percentage of participants who discontinued from the study drug due to an AE
time frame: Up to 52 weeks
Male or female participants at least 20 years old.
- 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
- 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
|Official title||A Phase III, Multicenter, Open-label Long-term Treatment Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy|
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