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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165268
• Other study ID #: MB102-066
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2010
• Last updated: November 16, 2016
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 7 days

Locations

Country	Name	City	State
United States	Profil Institute For Clinical Research, Inc.	Chula Vista	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin		Before 7 days of oral administration of 10 mg of dapagliflozin	No
Primary	The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin		After 7 days of oral administration of 10 mg of dapagliflozin	No
Secondary	Splay of the glucose titration curve		Before 7 days of oral administration of 10 mg of dapagliflozin	No
Secondary	Splay of the glucose titration curve		After 7 days of oral administration of 10 mg of dapagliflozin	No
Secondary	Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin		Study Day 7	No
Secondary	Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin		Study Day 8	No

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-066_CSR_synopsis