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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01165268

Enrollment

Registered

2010-07-19

Start date

2010-08-31

Completion date

2010-12-31

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGDapagliflozin

Tablets, Oral, 10 mg, Once daily, 7 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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%

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Splay of the glucose titration curve	Before 7 days of oral administration of 10 mg of dapagliflozin
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin	Study Day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026