Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With Type 2 diabetes mellitus (T2DM)

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 17.0Level: 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: EUCTR2014-003964-18-Outside-EU/EEA
• Lead Sponsor: Bristol-Myers Squibb Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-02
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Clinical diagnosis of T2DM
•Male and female subjects ages 10-17
•Body weight =50 kg
•Glycosylated hemoglobin (HbA1c) 6.5 to 10%

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
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