Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
NCT ID: NCT02564211
Last Updated: 2018-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
77 participants
INTERVENTIONAL
2015-10-26
2017-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ipragliflozin
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.
Ipragliflozin
one 50 mg tablet QD
Sitagliptin
one 50 mg tablet QD
Interventions
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Ipragliflozin
one 50 mg tablet QD
Sitagliptin
one 50 mg tablet QD
Eligibility Criteria
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Inclusion Criteria
* 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 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
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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153083
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-0431J-849
Identifier Type: OTHER
Identifier Source: secondary_id
0431J-849
Identifier Type: -
Identifier Source: org_study_id
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