Phase 1
Completed N=25
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)
Source: ClinicalTrials.gov NCT01557504 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 — 6; 7; 10; 12 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2 |
6; 7; 10; 12; 13; 10 | — |
| PRIMARY Number of Participants Who Successfully Swallowed Study Med on Day 4 |
6; 6; 8; 14; 8; 15 | — |
| PRIMARY Number of Participants Who Successfully Swallowed Study Med on Day 6 |
5; 7; 10; 11; 11; 12 | — |
| PRIMARY Number of Participants Who Successfully Swallowed Study Med on Day 9 |
9; 5; 9; 13; 12; 11 | — |
| PRIMARY Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR |
5940 | — |
| PRIMARY AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR |
5310 | — |
| PRIMARY AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR |
14200 | — |
| PRIMARY Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR |
6020 | — |
| PRIMARY Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR |
757 | — |
| PRIMARY Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR |
1490 | — |
| PRIMARY Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR |
1.52; 5.00 | — |
| PRIMARY Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR |
10.0 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
5; 5 | — |
| PRIMARY Number of Participants Who Experienced an Abnormal Vital Sign Value |
0; 0 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01557504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.