Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus Non-insulin dependent diabetes mellitus Drug therapy Pediatrics
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.

Detailed description:
Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying, and inhibiting glucagon secretion.

To date, alogliptin has not been studied in participants less than 18 years of age. As with adults, there is growing evidence of an increase in the prevalence of type 2 diabetes mellitus in children and adolescents.

This study is designed to determine the pharmacokinetic, pharmacodynamic, and safety profiles of alogliptin in children and adolescents with type 2 diabetes mellitus. These profiles will be compared with those of similarly matched adult participants with type 2 diabetes mellitus. Pharmacokinetic, pharmacodynamics, and safety endpoints will be analyzed.

Arms:
arm 1: Alogliptin 12.5 mg, tablets, orally, 1 dose only. arm 2: Alogliptin 25 mg, tablets, orally, 1 dose only. arm 3: Alogliptin 12.5 mg, tablets, orally, 1 dose only. arm 4: Alogliptin 25 mg, tablets, orally, 1 dose only. arm 5: Alogliptin 25 mg, tablets, orally, 1 dose only.

Interventions: intervention 1: Alogliptin
Intervention descriptions: intervention 1: Alogliptin tablets

Protocol document: