A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01472367
First received: November 11, 2011
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C), fasting plasma glucose (FPG) and the proportion of patients requiring glycemic rescue therapy in pediatric patients 10-17 years of age (inclusive) with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin monotherapy.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Metformin
Drug: Sitagliptin + Metformin FDC
Drug: Placebo to Metformin
Drug: Placebo to Sitagliptin + Metformin FDC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Pediatric Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Hemoglobin A1c (A1C) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study drug due to an adverse event [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: December 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin + Metformin FDC
Sitagliptin + Metformin fixed-dose combination (FDC) tablet 50/500, 50/850, or 50/1000 mg sitagliptin/metformin plus placebo to metformin twice daily for 20 weeks.
Drug: Sitagliptin + Metformin FDC
Sitagliptin + metformin FDC oral tablet 50/500, 50/850, or 50/1000 mg dosed twice daily.
Other Names:
  • MK-0431A
  • Janumet
Drug: Placebo to Metformin
Matching placebo to metformin administered twice daily.
Placebo Comparator: Placebo to Sitagliptin + Metformin FDC
Placebo to sitagliptin + metformin FDC plus metformin 500, 850, or 1000 mg twice daily for 20 weeks.
Drug: Metformin
Metformin oral tablets twice daily. Participants on a metformin daily dose of 1000, 1250, or 1275 mg at screening will be switched to a metformin daily dose of 1000 mg (500 mg twice a day); 1500, 1700, or 1750 mg will be switched to a metformin daily dose of 1700 mg (850 mg twice a day); 2000 mg or more will be switched to a metformin daily dose of 2000 mg (1000 mg twice a day).
Other Name: Glucophage
Drug: Placebo to Sitagliptin + Metformin FDC
Matching placebo to sitagliptin + metformin FDC oral tablet administered twice daily.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has Type 2 Diabetes Mellitus (T2DM)
  • Has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1.
  • A1C greater than or equal to 6.5% and less than or equal to 10.0% on metformin, greater than or equal to 1500 mg/day, for greater than or equal to 12 weeks. NOTE: Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated.
  • Between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday.
  • Participant and a family member or adult closely involved in the daily activities will participate in the participant's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed).

Exclusion Criteria:

  • Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when participant was diagnosed with diabetes).
  • Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
  • Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.
  • Participant has previously taken a dipeptidyl peptidase-IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or glucagon-like peptide-1 (GLP-1) receptor agonist (such as exenatide or liraglutide).
  • Exhibits abnormal growth patterns or is being treated with growth hormone.
  • History of idiopathic acute pancreatitis or chronic pancreatitis.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472367

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

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 0101) Recruiting
Canoga Park, California, United States, 91303
Call for Information (Investigational Site 0015) Recruiting
Clovis, California, United States, 93612
Call for Information (Investigational Site 0020) Recruiting
Los Angeles, California, United States, 90048
Call for Information (Investigational Site 0022) Recruiting
Sacramento, California, United States, 95821
Call for Information (Investigational Site 0021) Recruiting
San Diego, California, United States, 92123
United States, Colorado
Call for Information (Investigational Site 0024) Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Call for Information (Investigational Site 0300) Recruiting
Miami Lakes, Florida, United States, 33014
United States, Iowa
Call for Information (Investigational Site 0301) Recruiting
Iowa City, Iowa, United States, 52242
United States, Maine
Call for Information (Investigational Site 0012) Recruiting
Portland, Maine, United States, 04102
United States, Texas
Call for Information (Investigational Site 0017) Recruiting
Boerne, Texas, United States, 78006
Call for Information (Investigational Site 0019) Recruiting
Houston, Texas, United States, 77081
Call for Information (Investigational Site 0010) Recruiting
San Antonio, Texas, United States, 78229
Argentina
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Chile
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Santiago, Chile
Contact: Maria Elena Azara Hernandez    56 2 6558958      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Dominican Republic
Merck Sharp & Dohme Recruiting
Santo Domingo, Dominican Republic
Contact: Felipe Arbelaez    (787) 474-8200      
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Soraya Cedraro    507-282-7200      
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Ofer Sharon    972 9 9539310      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
Latvia
Merck Sharp & Dohme Latvija SIA Recruiting
Riga, Latvia
Contact: Andrius Bacevicius    370 52780243      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Andrius Bacevicius    370 52780243      
Malaysia
MSD Recruiting
Petaling Jaya, Malaysia
Contact: Boon Hock Yeoh    60 377181723      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Wellington, New Zealand
Contact: Gary Jankelowitz    61 2 8988 8246      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Eran Gefen    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Saudi Arabia
MSD (IA) Corp - SA Branch Recruiting
Riyadh, Saudi Arabia
Contact: Samer El-Ali    04 4269100      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Thanu Komolsai    66 2262 5746      
United Arab Emirates
Merck Sharp & Dohme Recruiting
Dubai, United Arab Emirates
Contact: Samer El-Ali    04 4269100      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01472367     History of Changes
Other Study ID Numbers: 0431A-170, CTRI/2012/09/003025
Study First Received: November 11, 2011
Last Updated: October 2, 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 October 29, 2014