Double-blind Sitagliptin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Ipragliflozin (MK-0431J-842)
NCT ID: NCT02577016
Last Updated: 2018-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
141 participants
INTERVENTIONAL
2015-11-05
2016-11-18
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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Sitagliptin + Ipragliflozin
Sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
Sitagliptin
50 mg tablet administered orally
Ipragliflozin
50 mg tablet administered orally as background medication
Placebo + Ipragliflozin
Placebo to sitagliptin, oral, once daily for 24 weeks plus ipragliflozin (base therapy), in addition to diet and exercise.
Placebo
Placebo to sitagliptin administered orally
Ipragliflozin
50 mg tablet administered orally as background medication
Interventions
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Sitagliptin
50 mg tablet administered orally
Placebo
Placebo to sitagliptin administered orally
Ipragliflozin
50 mg tablet administered orally as background medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Inadequate glycemic control on diet/exercise therapy and ipragliflozin 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, sitagliptin within 8 weeks prior to study participation.
* 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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Seino Y, Kaku K, Kadowaki T, Okamoto T, Sato A, Shirakawa M, O'Neill EA, Engel SS, Kaufman KD. A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin. Diabetes Obes Metab. 2021 Jun;23(6):1342-1350. doi: 10.1111/dom.14346. Epub 2021 Feb 28.
Other Identifiers
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153096
Identifier Type: REGISTRY
Identifier Source: secondary_id
0431J-842
Identifier Type: -
Identifier Source: org_study_id
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