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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)

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
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Sitagliptin/metformin XR
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Pharmacokinetics and the Ability for Pediatric Patients With Type 2 Diabetes to Swallow MK-0431A XR Tablets

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: Placebo
Matching placebo to fixed dose combination tablet of sitagliptin and metformin

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01557504     History of Changes
Other Study ID Numbers: 0431A-296
Study First Received: March 16, 2012
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014