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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01165268
First received: July 16, 2010
Last updated: June 9, 2014
Last verified: June 2014
  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:


Further study details as provided by AstraZeneca:

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: 65
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01165268     History of Changes
Other Study ID Numbers: MB102-066
Study First Received: July 16, 2010
Last Updated: June 9, 2014
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 July 29, 2014