Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)
NCT ID: NCT02577003
Last Updated: 2018-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2015-11-09
2016-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ipragliflozin + Sitagliptin
Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
Ipragliflozin
50 mg tablet administered orally
Sitagliptin
Background medication; 50 mg tablet administered orally
Placebo + Sitagliptin
Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.
Placebo
Placebo to ipragliflozin tablet administered orally
Sitagliptin
Background medication; 50 mg tablet administered orally
Interventions
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Ipragliflozin
50 mg tablet administered orally
Placebo
Placebo to ipragliflozin tablet administered orally
Sitagliptin
Background medication; 50 mg tablet administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
* HbA1c ≥7.0% and ≤10.0% before study start
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15.
Other Identifiers
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153097
Identifier Type: REGISTRY
Identifier Source: secondary_id
0431J-843
Identifier Type: -
Identifier Source: org_study_id
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