Back to resultsCharacterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
Eligibility 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%
Sites / Locations
- Profil Institute For Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dapagliflozin (T2DM)
Dapagliflozin (Healthy Subjects)
Arm Description
Outcomes
Primary Outcome Measures
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Secondary Outcome Measures
Splay of the glucose titration curve
Splay of the glucose titration curve
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Full Information
NCT ID
NCT01165268
First Posted
July 16, 2010
Last Updated
November 16, 2016
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01165268
Brief Title
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin (T2DM)
Arm Type
Active Comparator
Arm Title
Dapagliflozin (Healthy Subjects)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Tablets, Oral, 10 mg, Once daily, 7 days
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Splay of the glucose titration curve
Time Frame
Before 7 days of oral administration of 10 mg of dapagliflozin
Title
Splay of the glucose titration curve
Time Frame
After 7 days of oral administration of 10 mg of dapagliflozin
Title
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Time Frame
Study Day 7
Title
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
Time Frame
Study Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institute For Clinical Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3651&filename=MB102-066_CSR_synopsis.pdf
Description
MB102-066_CSR_synopsis
Learn more about this trial
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
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