Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2007-11-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Arm 1
2.5 mg
Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Arm 2
10 mg
Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Arm 3
20 mg
Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Arm 4
placebo
Tablets, Oral, 0 mg, once daily, up to 14 days
Interventions
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Dapagliflozin
Tablets, Oral, once daily up, to 14 days
placebo
Tablets, Oral, 0 mg, once daily, up to 14 days
Eligibility Criteria
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Inclusion Criteria
* Ages 20 to 70 years old
* Established diagnosis of T2DM
* BMI \< 32 kg/m2
* Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
* HbA1C 6.0 - 10.0%
Exclusion Criteria
* History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
* History of incontinence or bladder dysfunction including nocturia
20 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers K.K.
Locations
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Local Institution
Suita, Osaka, Japan
Countries
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References
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Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x.
Other Identifiers
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MB102-025
Identifier Type: -
Identifier Source: org_study_id
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