Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01294423
Last Updated: 2014-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2011-02-28
2012-03-31
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
QUADRUPLE
Study Groups
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1
Dapagliflozin 5 mg
Dapagliflozin
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
2
Dapagliflozin 10 mg
Dapagliflozin
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
3
Placebo
Matching placebo for Dapagliflozin 5mg/10mg oral dose
Interventions
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Dapagliflozin
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Dapagliflozin
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Placebo
Matching placebo for Dapagliflozin 5mg/10mg oral dose
Eligibility Criteria
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Inclusion Criteria
* Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization
Exclusion Criteria
* FPG \>240 mg/dL before randomization
* Subjects who have history of unstable or rapidly progressing renal disease
* Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
* Significant cardiovascular history
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jisin Yang, MD
Role: STUDY_DIRECTOR
AstraZeneca KK
Locations
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Research Site
Noda, Chiba, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Chitose-shi, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Takasago-shi, Hyōgo, Japan
Research Site
Hakusan-shi, Ishikawa-ken, Japan
Research Site
Sanuki-shi, Kagawa-ken, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
Research Site
Ebina-shi, Kanagawa, Japan
Research Site
Kamakura-shi, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Matsumoto-shi, Nagano, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Ōtsu, Shiga, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Meguro-ku,, Tokyo, Japan
Research Site
Ōta-ku, Tokyo, Japan
Research Site
Tokyo, Tokyo, Japan
Research Site
Takaoka-shi, Toyama, Japan
Research Site
Toyama, Toyama, Japan
Countries
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References
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Kaku K, Kiyosue A, Inoue S, Ueda N, Tokudome T, Yang J, Langkilde AM. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014 Nov;16(11):1102-10. doi: 10.1111/dom.12325. Epub 2014 Jul 8.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Related Links
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Related Info
CSR-D1692C00006.pdf
D1692C00006\_Clinical\_Study\_Protocol\_and\_Amendment
Other Identifiers
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D1692C00006
Identifier Type: -
Identifier Source: org_study_id
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