A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

• Status: Completed
• Trial end date: 2014-04-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess:

1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years

2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking)

3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.

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

Details

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

Criteria

Inclusion Criteria:

• Female participant of reproductive potential must not be pregnant and agrees to use (and/or have their partner use) two acceptable methods of birth control

• T2DM diagnosed by American Diabetes Association criteria

• No clinically significant abnormality on electrocardiogram

• No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

• Nonsmoker

Exclusion Criteria:

• Mental or legal incapacitation

• Estimated creatinine clearance of 80 mL/min or lower

• History of stroke, chronic seizures, or major neurological disorder

• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

• History of neoplastic disease

• Unable to refrain from or anticipates the use of any medication (with the exception of metformin and thyroid hormone) from approximately 2 weeks before the first dose of study drug through the poststudy visit

• Consumes alcohol or consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages

• Had surgery, donated or lost 1 unit of blood, or participated in another investigational study within the past 4 weeks

• History of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

• Currently a regular user (including illicit drugs) or has a history of drug (including alcohol) abuse

• Lactose intolerant