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 |
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.
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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