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Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01165268
First received: July 16, 2010
Last updated: February 22, 2011
Last verified: November 2010
History of Changes
  Purpose

It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal reabsorption similarly in healthy subjects and in subjects with T2DM.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Dapagliflozin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin [ Time Frame: Before 7 days of oral administration of 10 mg of dapagliflozin ] [ Designated as safety issue: No ]
  • The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin [ Time Frame: After 7 days of oral administration of 10 mg of dapagliflozin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Splay of the glucose titration curve [ Time Frame: Before 7 days of oral administration of 10 mg of dapagliflozin ] [ Designated as safety issue: No ]
  • Splay of the glucose titration curve [ Time Frame: After 7 days of oral administration of 10 mg of dapagliflozin ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin [ Time Frame: Study Day 7 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin [ Time Frame: Study Day 8 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dapagliflozin (T2DM) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days
Active Comparator: Dapagliflozin (Healthy Subjects) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for T2DM

  • Diagnosis of T2DM
  • 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%

Inclusion criteria for healthy subjects:

  • Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)

Inclusion criteria for all subjects:

  • 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 for all subjects:

  • Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
  • 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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165268

Locations
United States, California
Profil Institute For Clinical Research, Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01165268     History of Changes
Other Study ID Numbers: MB102-066
Study First Received: July 16, 2010
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013