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)

• Number of Participants That Successfully Swallowed Study Drug [ Time Frame: Up to 14 Days Following Last Dose of Study Drug ] [ Designated as safety issue: No ]
• Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 14 Days Following Last Dose of Study Drug ] [ Designated as safety issue: Yes ]
• Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin and Metformin Following Single Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Area Under the Curve 0 to 24 Hours (AUC 0-24) of Sitagliptin and Metformin Following Single Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin and Metformin Following Single Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Maximum Plasma Concentration (Cmax) of Sitagliptin and Metformin Following Single Dose Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Time to Maximum Plasma Concentration (Tmax) of Sitagliptin and Metformin Following Single Dose Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Apparent Terminal Half Life (T 1/2) of Sitagliptin and Metformin Following Single Dose Administration of MK-0431A XR [ Time Frame: Up to 72 Hours Post Dose ] [ Designated as safety issue: No ]
• Number of Participants Experiencing an Abnormal Vital Sign [ Time Frame: Up to 14 Days Following Last Dose of Study Drug ] [ Designated as safety issue: Yes ]
• Number of Participants That Discontinued Study Drug Due to an AE [ Time Frame: Up to Day 9 ] [ Designated as safety issue: Yes ]

• Number of participants who were able to swallow study drug [ Time Frame: Baseline through approximately 10 to 14 days following last dose ] [ Designated as safety issue: No ]
• Number of participants who experienced at least one adverse event [ Time Frame: Through approximately 10 to 14 days following last dose ] [ Designated as safety issue: Yes ]
• Pharmacokinetic analysis of sitagliptin and metformin: Area under the curve (AUC) 0 to infinity, AUC 0 to last, and AUC 0 to 24 hours [ Time Frame: From Baseline up to 72 hours post-dose ] [ Designated as safety issue: No ]
• Pharmacokinetic analysis of sitagliptin and metformin: maximum concentration (Cmax) [ Time Frame: From Baseline up to 72 hours post-dose ] [ Designated as safety issue: No ]
• Pharmacokinetic analysis of sitagliptin and metformin: time to maximum concentration (Tmax) [ Time Frame: From Baseline up to 72 hours post-dose ] [ Designated as safety issue: No ]
• Number of participants who experienced at least one abnormal vital sign [ Time Frame: Through approximately 10 to 14 days following last dose ] [ Designated as safety issue: Yes ]

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.

• Drug: Sitagliptin/metformin XR
  Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release metformin 1000 mg
  Other Names:

  • MK-0431A XR
  • Janumet XR
• Drug: Placebo
  Matching placebo to fixed dose combination tablet of sitagliptin and metformin

• Experimental: Sitagliptin/metformin XR followed by placebo
  Day 1 (Period 1): participants will receive a single dose of 2 sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants will receive a single dose of 2 matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of 2 matching placebo tablets with the evening meal.
  Interventions:

  • Drug: Sitagliptin/metformin XR
  • Drug: Placebo
• Placebo Comparator: Placebo only
  Days 1-4 (Period 1): participants will receive a single dose of 2 matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of 2 matching placebo tablets with the evening meal.
  Intervention: Drug: Placebo

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