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A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Sitagliptin phosphate (Drug); Comparator: matching placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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

Clinical Details

Official title: A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Participants Who Experienced at Least One Adverse Event

Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin

Secondary outcome:

Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin

Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin

Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin

Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo


Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: July 2008
Last updated: August 7, 2015

Page last updated: August 23, 2015

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