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 AM1)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:5/3/2014
Start Date:July 2012
End Date:March 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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

The purpose of this study is to assess:

1. the safety and tolerability of 2 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 2
sitagliptin 50 mg/metformin 1000 mg XR tablets or 2 matching placebo tablets (excluding
marking)

3. the pharmacokinetics of sitagliptin and metformin following the administration of 2
sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM,
aged 10 to 17 years.


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
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