Clinical trial NCT01557504: 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)
Official title: A Study to Assess the Pharmacokinetics and the Ability for Pediatric Patients With Type 2 Diabetes to Swallow MK-0431A XR Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2
timeFrame: Day 2
measure: Number of Participants Who Successfully Swallowed Study Med on Day 4
timeFrame: Day 4
measure: Number of Participants Who Successfully Swallowed Study Med on Day 6
timeFrame: Day 6
measure: Number of Participants Who Successfully Swallowed Study Med on Day 9
timeFrame: Day 9
measure: Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
measure: AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
measure: Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR
timeFrame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
measure: Number of Participants Who Experienced an Abnormal Vital Sign Value
timeFrame: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)
measure: Number of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: