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A Study of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-289)

This study is currently recruiting participants.
Verified October 2017 by Merck Sharp & Dohme Corp.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760447
First Posted: January 4, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to assess the safety and efficacy of the addition of sitagliptin (administered as MK-0431A XR) compared with the addition of placebo to therapy with extended-release metformin (metformin XR) for the treatment of type 2 diabetes mellitus (T2DM) in pediatric participants with inadequate glycemic control on metformin therapy (alone or in combination with insulin). The primary hypothesis is that the addition of sitagliptin reduces hemoglobin A1c (A1C) more than the addition of placebo after 20 weeks of treatment.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin + Metformin XR FDC Drug: Placebo to Sitagliptin + Metformin XR Drug: Metformin XR Drug: Placebo to metformin XR Drug: Insulin glargine Biological: Background insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 XR (a Fixed-dose Combination Tablet of Sitagliptin and Extended-release Metformin) in Pediatric Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin)

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) [ Time Frame: Baseline and Week 20 ]
  • Number of participants who experienced at least one adverse event [ Time Frame: up to 54 weeks ]
  • Number of participants who discontinued study drug due to an adverse event [ Time Frame: Up to 54 weeks ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 20 ]
  • Percentage of participants with A1C goals (<7%; <6.5%) [ Time Frame: Week 20 ]

Estimated Enrollment: 90
Actual Study Start Date: February 17, 2013
Estimated Study Completion Date: January 23, 2020
Estimated Primary Completion Date: January 23, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin + Metformin XR FDC
Phase A: two sitagliptin + extended-release (XR) metformin fixed-dose combination (FDC) tablets (MK-0431A XR) orally daily (total daily dose: 100 mg sitagliptin and 1000, 1500 or 2000 mg metformin XR) plus two placebo to metformin XR tablets plus/minus background insulin for 20 weeks. Insulin glargine may be administered, or background insulin may be up-titrated as glycemic rescue therapy during Phase A of the study. Phase B: two sitagliptin + metformin XR FDC tablets orally daily (total daily dose: 100 mg sitagliptin and 1000, 1500 or 2000 mg metformin XR) plus two placebo to metformin XR tablets plus/minus background insulin for 34 weeks. Insulin glargine may be administered, or background insulin may be up-titrated during Phase B of the study depending on the participants' glucose and A1C levels.
Drug: Sitagliptin + Metformin XR FDC
Sitagliptin + Metformin XR fixed-dose combination tablet (sitagliptin/metformin: 50/500 mg, 50/1000 mg) administered with a meal, preferably in the evening
Drug: Placebo to metformin XR
Matching placebo to metformin XR tablet administered with a meal, preferably in the evening
Drug: Insulin glargine
The insulin regimen and dosing will be at the discretion of the investigator (based on locally accepted, national, or international guidelines for the indication and use of insulin glargine). When thresholds for rescue are met, participants who are not on background insulin will initiate insulin glargine.
Other Name: Lantus
Biological: Background insulin
Participants who enter the study on background insulin will continue on the same dose and formulation of insulin throughout the study. When thresholds for rescue are met, participants who have entered the study on background insulin will uptitrate their background insulin dose.
Placebo Comparator: Placebo to Sitagliptin + Metformin XR FDC
Phase A: two placebo to sitagliptin + metformin XR FDC tablets orally daily plus two metformin XR tablets (total daily dose: 1000, 1500 or 2000 mg) plus/minus background insulin for 20 weeks. Insulin glargine may be administered, or background insulin may be up-titrated as glycemic rescue therapy during Phase A of the study. Phase B: two placebo to sitagliptin + metformin XR FDC tablets orally daily plus two metformin XR tablets (total daily dose: 1000, 1500 or 2000 mg) plus/minus background insulin for 34 weeks. Insulin glargine may be administered, or background insulin may be up-titrated during Phase B of the study depending on the participants' glucose and A1C levels.
Drug: Placebo to Sitagliptin + Metformin XR
Matching placebo to Sitagliptin + Metformin XR fixed-dose combination tablet administered with a meal, preferably in the evening
Drug: Metformin XR
Metformin XR tablet (500 mg, 1000 mg) administered with a meal, preferably in the evening
Other Name: Glucophage® XR
Drug: Insulin glargine
The insulin regimen and dosing will be at the discretion of the investigator (based on locally accepted, national, or international guidelines for the indication and use of insulin glargine). When thresholds for rescue are met, participants who are not on background insulin will initiate insulin glargine.
Other Name: Lantus
Biological: Background insulin
Participants who enter the study on background insulin will continue on the same dose and formulation of insulin throughout the study. When thresholds for rescue are met, participants who have entered the study on background insulin will uptitrate their background insulin dose.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has T2DM
  • 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) without insulin for greater than or equal to 12 weeks OR A1C greater than or equal to 7% and less than or equal to 10.0% on metformin (greater than or equal to 1500 mg/day) and insulin 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 for greater than or equal to 12 weeks may be eligible if there is documentation that higher doses are not tolerated.
  • Between 10 and 17 years of age (inclusive)
  • Male, or female who is unlikely to conceive (non-sterilized, and is not sexually active or agrees to abstain from heterosexual activity or agrees to use an adequate method of contraception) during the study and for 14 days after the last dose of study drug

Exclusion Criteria:

  • Has type 1 diabetes mellitus
  • Has monogenic diabetes or secondary diabetes
  • Has previously taken a dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, saxagliptin, or linagliptin) or glucagon-like peptide-1 (GLP-1) receptor agonist (such as exenatide or liraglutide)
  • Is on or likely to require treatment for > or =2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
  • Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
  • History of congenital heart disease or cardiovascular disease other than hypertension
  • History of active liver disease (other than non-alcoholic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Active neuropathy (such as nephrotic syndrome or glomerulonephritis)
  • Chronic myopathy, mitochondrial disorder or a progressive neurological or neuromuscular disorder
  • Human immunodeficiency virus (HIV)
  • Hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndromes)
  • Is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
  • History of malignancy for < or =5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of idiopathic acute pancreatitis or chronic pancreatitis
  • History of recreational or illicit drug use, or of alcohol abuse or

dependence (within the past year)

  • Has donated blood products or has had phlebotomy of >10% of estimated

total blood volume within 8 weeks of study participation, or intends to donate

blood products or receive blood products within the projected duration of the study

  • Is pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760447


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

  Hide Study Locations
Locations
United States, Alabama
Call for Information (Investigational Site 0450) Recruiting
Birmingham, Alabama, United States, 35233-1711
United States, California
Call for Information (Investigational Site 0464) Recruiting
Los Angeles, California, United States, 90027
United States, District of Columbia
Call for Information (Investigational Site 0746) Recruiting
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Call for Information (Investigational Site 0452) Recruiting
Miami, Florida, United States, 33126
United States, Louisiana
Call for Information (Investigational Site 0749) Recruiting
New Orleans, Louisiana, United States, 70115
United States, Michigan
Call for Information (Investigational Site 0474) Recruiting
Detroit, Michigan, United States, 48201
United States, Mississippi
Call for Information (Investigational Site 0744) Recruiting
Jackson, Mississippi, United States, 39216
United States, North Carolina
Call for Information (Investigational Site 0805) Recruiting
Wilmington, North Carolina, United States, 28403
United States, Oregon
Call for Information (Investigational Site 0751) Recruiting
Portland, Oregon, United States, 97239
United States, Texas
Call for Information (Investigational Site 0456) Recruiting
Fort Worth, Texas, United States, 76104
United States, Washington
Call for Information (Investigational Site 0807) Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Call for Information (Investigational Site 0733) Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
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      
Costa Rica
Merck Sharp & Dohme Recruiting
San Jose, Costa Rica
Contact: Soraya Cedraro    507-282-7200      
Georgia
Merck Sharp & Dohme IDEA, Inc. Recruiting
Tbilisi, Georgia
Contact: Eran Gefen    38 (044) 393 74 80      
Greece
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Lazaros Poughias    30 2109897322      
Guatemala
MSD CARD Recruiting
Guatemala, Guatemala
Contact: Soraya Cedraro    507-282-7200      
Honduras
MSD CARD Recruiting
Tegucigalpa, Honduras
Contact: Soraya Cedraro    507-282-7200      
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Szabolcs Barotfi    36 1 888 5300      
Israel
Merck Sharp & Dohme Co. Ltd. Recruiting
Hod Hasharon, Israel
Contact: Gally Teper    972-9-9533310      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
Mauritius
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Port Louis, Mauritius
Contact: Cem Ozesen    90 212 3361260      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Moldova, Republic of
Merck Sharp & Dohme IDEA, Inc. Recruiting
Chisinau, Moldova, Republic of
Contact: Tatyana Gots    38 044 393-7480      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
Serbia
Merck Sharp & Dohme Recruiting
Belgrade, Serbia
Contact: Eran Gefen    38 (044) 393 74 80      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Sri Lanka
MSD Pharmaceuticals Pvt. Ltd Recruiting
Colombo, Sri Lanka
Contact: Swashraya Shah    91 22 67898888      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01760447     History of Changes
Other Study ID Numbers: 0431A-289
2012-004035-23 ( EudraCT Number )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Last Update Posted: October 9, 2017
Last Verified: October 2017

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