Clinical trial NCT00730275: A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Official title: A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Males or females who are 10 - 17 years of age
* History of type 2 diabetes
* Nonsmoker
* No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

* History of diabetic ketoacidosis
* History of stroke, chronic seizures or major neurological disorder
* Consumes alcohol
* Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
* Unable to swallow tablets
* Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
* History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
* History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

* Has an estimated creatinine clearance of less than or equal to 80 mL/min

Primary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Pre-study through 10 to 14 days following administration of study drug
measure: Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin
timeFrame: Pre-dose through 72 hours post-dose
Secondary outcomes:
measure: Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin
timeFrame: Pre-dose through 72 hours post-dose
measure: Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin
timeFrame: Pre-dose through 72 hours post-dose
measure: Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin
timeFrame: Pre-dose through 72 hours post-dose
measure: Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo
timeFrame: Pre-dose through 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA. A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes. Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13.