Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT01165268
Last Updated: 2016-11-17
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
24 participants
INTERVENTIONAL
2010-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Dapagliflozin (T2DM)
Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days
Dapagliflozin (Healthy Subjects)
Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days
Interventions
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Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days
Eligibility Criteria
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Inclusion Criteria
* Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
* Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
* Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%
* Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
* Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion \< 300 mg/g creatinine)
* Body Mass Index (BMI) of 18 to 38 kg/m²
* Men and women, ages 18 to 65 years, inclusive
Exclusion Criteria
* Subjects with T2DM with fasting plasma glucose \> 200 mg/dL, healthy subjects with fasting plasma glucose \> 105 mg/dL
* Subjects with T2DM with HbA1C \> 10.0%, healthy subjects with HbA1C \> 6.8%
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Profil Institute For Clinical Research, Inc.
Chula Vista, California, United States
Countries
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Related Links
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Other Identifiers
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MB102-066
Identifier Type: -
Identifier Source: org_study_id