Renal Mechanism of Action/Splay vs. TmG (MOA)

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Diabetes, NOS

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726505

MB102-020

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Subjects with T2DM - Dapagliflozin 5 mg

Treatment:

Drug: Dapagliflozin

Group 2

Active Comparator group

Description:

Subjects with T2DM - Dapagliflozin 20 mg

Treatment:

Drug: Dapagliflozin

Group 3

Active Comparator group

Description:

Healthy Subjects - Dapagliflozin 20 mg

Treatment:

Drug: Dapagliflozin