Phase 1
Completed N=35
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Source: ClinicalTrials.gov NCT00730275 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Number of Participants Who Experienced at Least One Adverse Event — 3; 1; 1; 2 participants
Summary
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
3; 1; 1; 2 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin |
3438; 5869; 12965 | — |
| SECONDARY Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin |
366; 666; 1876 | — |
| SECONDARY Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin |
3.0; 3.0; 2.5 | — |
| SECONDARY Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin |
12.1; 11.2; 11.7 | — |
| SECONDARY Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo |
73.98; 80.53; 87.96; 6.76; 53.98; 62.78 | — |
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
Data sourced from ClinicalTrials.gov (NCT00730275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.