Status:
COMPLETED
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00730275
Start Date
July 18 2008
End Date
February 14 2011
Last Update
May 12 2017
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