Phase I Multiple-Ascending Dose (Japan) (MAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538174

MB102-025

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days

Enrollment: 36 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese male and female subjects
• Ages 20 to 70 years old
• Established diagnosis of T2DM
• BMI < 32 kg/m2
• Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
• HbA1C 6.0 - 10.0%

Exclusion criteria

• Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
• History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
• History of incontinence or bladder dysfunction including nocturia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Description:

2.5 mg

Treatment:

Drug: Dapagliflozin

Arm 2

Experimental group

Description:

10 mg

Treatment:

Drug: Dapagliflozin

Arm 3

Experimental group

Description:

20 mg

Treatment:

Drug: Dapagliflozin

Arm 4

Placebo Comparator group

Treatment:

Drug: placebo