Clinical Trial Details

NCT ID: NCT01760447
Date Last Changed: October 6, 2017

Overview

Research Study Summary

A clinical research study for the treatment of Type 2 Diabetes Mellitus

Research Study 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)

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
10 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Merck Sharp & Dohme Corp.
Duration
83 Months
Facility Type
N/A
Compensation

Eligibility

All ages 10 Years to 17 Years

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

Site Locations (34)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233-1711 Call for Information (Investigational Site 0450)
United States California Los Angeles 90027 Call for Information (Investigational Site 0464)
United States District of Columbia Washington, D.C. 20010 Call for Information (Investigational Site 0746)
United States Florida Miami 33126 Call for Information (Investigational Site 0452)
United States Louisiana New Orleans 70115 Call for Information (Investigational Site 0749)
United States Michigan Detroit 48201 Call for Information (Investigational Site 0474)
United States Mississippi Jackson 39216 Call for Information (Investigational Site 0744)
United States North Carolina Wilmington 28403 Call for Information (Investigational Site 0805)
United States Oregon Portland 97239 Call for Information (Investigational Site 0751)
United States Texas Fort Worth 76104 Call for Information (Investigational Site 0456)
United States Washington Tacoma 98405 Call for Information (Investigational Site 0807)
United States Wisconsin Milwaukee 53226 Call for Information (Investigational Site 0733)
Australia North Ryde Merck Sharp & Dohme
Australian Medical Information Centre
61 2 8988 8428
Brazil Sao Paulo MSD Brasil
MSD Online
0800 012 22 32
Bulgaria Sofia Merck Sharp & Dohme Bulgaria EOOD
Eran Gefen
38 (044) 393 74 80
Chile Santiago Merck Sharp & Dohme (I.A.) Corp.
Maria Elena Azara Hernandez
56 2 6558958
Colombia Bogota MDS Colombia SAS
Francesca Carvajal
57 1219109011090
Costa Rica San Jose Merck Sharp & Dohme
Soraya Cedraro
507-282-7200
Georgia Tbilisi Merck Sharp & Dohme IDEA, Inc.
Eran Gefen
38 (044) 393 74 80
Greece Alimos Vianex, S.A. / MSD
Lazaros Poughias
30 2109897322
Guatemala Guatemala MSD CARD
Soraya Cedraro
507-282-7200
Honduras Tegucigalpa MSD CARD
Soraya Cedraro
507-282-7200
Hungary Budapest MSD Pharma Hungary Kft.
Szabolcs Barotfi
36 1 888 5300
Israel Hod Hasharon Merck Sharp & Dohme Co. Ltd.
Gally Teper
972-9-9533310
Italy Rome MSD Italia S.r.l.
Patrizia Nardini
39 06 361911
Mauritius Port Louis Merck Sharp & Dohme Ilaclari Ltd. Sti
Cem Ozesen
90 212 3361260
Mexico Mexico City MSD
Juan Marques
52 55254819608
Moldova, Republic of Chisinau Merck Sharp & Dohme IDEA, Inc.
Tatyana Gots
38 044 393-7480
Philippines Makati Merck Sharp & Dohme (I.A.) Corporation
Cesar Recto
632 784 9500
Russian Federation Moscow Merck Sharp & Dohme IDEA, Inc.
Tatiana Serebriakova
74959167100, EXT.366
Serbia Belgrade Merck Sharp & Dohme
Eran Gefen
38 (044) 393 74 80
South Africa Midrand MSD (Pty) LTD South Africa
Khanyi Mzolo
27 11 655 3140
Sri Lanka Colombo MSD Pharmaceuticals Pvt. Ltd
Swashraya Shah
91 22 67898888
Ukraine Kiev MSD Ukraine LLC
Eran Gefen
38 (044) 393 74 80

Contact

Toll Free Number
1-888-577-8839

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