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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin/metformin XR; Placebo; Metformin; Thyroid hormone
Intervention description: Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg).; Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings.; Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.; Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Hormones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility 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