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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

NCT01165268•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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%
•Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
•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

•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%

Locations (1)

Profil Institute For Clinical Research, Inc.

Chula Vista, California, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

November 17, 2016

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Dapagliflozin

DRUG

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

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Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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