Renal Mechanism of Action/Splay vs. TmG

Phase 1TerminatedNCT00726505

AstraZeneca1 enrolled

Overview

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetes, NOS

Interventions

DapagliflozinDRUG

Tablets, Oral, Once Daily, up to 29 days:

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects * Age 18 to 65 years * BMI 18 to 35 kg/m2 * Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin * No evidence of impaired renal function Exclusion Criteria: * Unwilling or unable to use an acceptable method of birth control * Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B * Exposure to insulin * Use of exclusionary concomitant medications * Evidence of significant kidney disease or any other significant medical or psychiatric disorder

Locations (1)

University Of Texas Health Center At San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

The change in urinary glucose excretion dynamics

Time frame: after 7 days of treatment

Secondary Outcomes

Differences in urinary glucose between healthy and diabetic subjects

Time frame: at 7 days

Changes in liver glucose production

Time frame: at one day

Glucose effects on tubular markers

Time frame: at one day

Data from ClinicalTrials.gov

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