Clinical trial NCT01165268: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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%

Primary outcomes:
measure: The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
timeFrame: Before 7 days of oral administration of 10 mg of dapagliflozin
measure: The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
timeFrame: After 7 days of oral administration of 10 mg of dapagliflozin
Secondary outcomes:
measure: Splay of the glucose titration curve
timeFrame: Before 7 days of oral administration of 10 mg of dapagliflozin
measure: Splay of the glucose titration curve
timeFrame: After 7 days of oral administration of 10 mg of dapagliflozin
measure: Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
timeFrame: Study Day 7
measure: Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin
timeFrame: Study Day 8
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute For Clinical Research, Inc.
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: