PK Study of Dapagliflozin in Pediatric Subjects with T2DM

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005225-40-Outside-EU/EEA
• Lead Sponsor: Bristol-Myers Squibb Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-27
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Clinical diagnosis of T2DM
• Male and female subjects ages 10-17
• HbA1c >6 to <10%

Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Fasting plasma glucose (FPG) > 240 mg/dL at screening
• Abnormal renal function
• Active liver disease and/or significant abnormal liver function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified