Type 2 Diabetes Mellitus | Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Type 2 Diabetes Mellitus research study
What is the primary objective of this study?
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
Who is eligible to participate?
Inclusion Criteria: - Clinical diagnosis of T2DM - Male and female subjects ages 10-17 - Body weight ≥50 kg - Glycosylated hemoglobin (HbA1c) 6.5 to 10% Exclusion Criteria: - Fasting plasma glucose (FPG) > 240 mg/dL at screening - Abnormal renal function - Active liver disease and/or significant abnormal liver function
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 2 Diabetes Mellitus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Metformin immediate release (IR)Tablet, Oral, 1000 mg, twice daily, 1 day
Drug:SaxagliptinTablet, Oral, 5 mg, single-dose, 1 day
Drug:Metformin IRTablet, Oral, 1000 mg, twice daily, 5 days
Drug:Saxagliptin/Metformin XR FDCTablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).
Drug:Metformin XRTablet, Oral, 500 mg, Single-dose of 4 tablets
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Start Date: September 2012
Completed Date: June 2013
Phase: Phase 1
Primary Outcome: Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
Secondary Outcome: Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities
Study sponsors, principal investigator, and references
Principal Investigator: Bristol-Myers Squibb
Lead Sponsor: AstraZeneca