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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01557504
First received: March 16, 2012
Last updated: May 20, 2014
Last verified: May 2014

March 16, 2012
May 20, 2014
July 2012
April 2014   (final data collection date for primary outcome measure)
  • 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 ]
Complete list of historical versions of study NCT01557504 on ClinicalTrials.gov Archive Site
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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)
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01557504
0431A-296
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP