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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 AM1)

This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01557504
First received: March 16, 2012
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557504

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, California
Call for Information (Investigational Site 0002) Recruiting
Los Angeles, California, United States, 90048
United States, Missouri
Call for Information (Investigational Site 0001) Recruiting
Kansas City, Missouri, United States, 64108
United States, Texas
Call for Information (Investigational Site 0003) Recruiting
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01557504     History of Changes
Other Study ID Numbers: 0431A-296
Study First Received: March 16, 2012
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013