Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
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|ClinicalTrials.gov Identifier: NCT02564211|
Recruitment Status : Completed
First Posted : September 30, 2015
Results First Posted : March 14, 2018
Last Update Posted : September 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Ipragliflozin Drug: Sitagliptin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 26, 2015|
|Actual Primary Completion Date :||March 7, 2017|
|Actual Study Completion Date :||March 7, 2017|
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.
one 50 mg tablet QD
one 50 mg tablet QD
- Percentage of Participants Who Experienced at Least 1 Adverse Event (AE) [ Time Frame: Up to 54 weeks ]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.
- Percentage of Participants Who Had Study Drug Discontinued Due to an AE [ Time Frame: Up to 52 weeks ]The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.
- Change From Baseline in HbA1c [ Time Frame: Baseline and Week 52 ]Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564211
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|