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

• Status: Completed
• Trial end date: 2011-02-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Sitagliptin Phosphate

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