Clinical Trial Details

NCT ID: NCT01485614
Date Last Changed: August 30, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Sitagliptin, Metformin, Placebo to sitagliptin and Placebo to metformin for patients with Diabetes Mellitus or Type 2 Diabetes

Research Study Title

A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Purpose

The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control. The primary hypothesis for this study is that sitagliptin reduces A1C more than 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:

  • Type 2 Diabetes Mellitus (T2DM)

  • Has not received treatment with an antihyperglycemic agent (AHA) for ≥12 weeks prior to the Screening Visit/Visit 1, or is on a stable dose of insulin (without any other AHA) for at least 12 weeks prior to the Screening Visit/Visit 1. At screening, participants on insulin doses that are not stable can have their insulin doses adjusted and be eligible to participate after their dose remains stable for ≥12 weeks, if they meet all other eligibility criteria. In India, only participants on stable doses of insulin will be eligible.

  • An A1C of ≥6.5% and ≤10.0% (For participants on insulin: an A1C ≥7.0% and ≤10.0%).

Exclusion Criteria:

  • History of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD (Glutamic Acid Decarboxylase) or (Islet cell autoantigen) ICA-512.

  • 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 and/or positive test for ketonemia requiring immediate initiation of antihyperglycemic therapy.

  • Previously taken a DPP-4 (Dipeptidyl peptidase-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or (Glucagon-like peptide-1) GLP-1 receptor agonist (such as exenatide or liraglutide).

  • Hypersensitivity or contraindication (according to the product circular in the country of the investigational site) to metformin.

  • Chronic treatment with a medication known to cause weight gain within 30 days of study start or weight loss or increased blood glucose within 8 weeks of study start or treated with an anti-psychotic within the past 12 weeks.

  • On a weight loss program and not in the maintenance phase or have undergone bariatric surgery within 12 months prior to study start.

  • On or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.

  • Undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study.

  • History of congenital heart disease or cardiovascular disease other than hypertension.

  • Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.

  • Active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).

  • Chronic myopathy, mitochondrial disorder, or a progressive neurological or neuromuscular disorder (e.g., polymyositis, or multiple sclerosis).

  • Human immunodeficiency virus (HIV) as assessed by medical history.

  • Clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome).

  • Under treatment for hyperthyroidism.

  • Exhibits abnormal growth patterns or is being treated with growth hormone.

  • History of malignancy or clinically important hematologic disorder.

  • History of idiopathic acute pancreatitis or chronic pancreatitis.

  • Known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year).

  • Donated blood products or has had phlebotomy of > 10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study.

  • Pregnant, has a positive urine pregnancy test at Screening Visit/Visit 1, is expecting to conceive within the projected duration of the study, or is breast-feeding.

  • Exclusionary laboratory values.

Site Locations (48)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233-1711 Call for Information (Investigative Site 0312)
United States California Clovis 93612 Call for Information (Investigational Site 0013)
United States California Los Angeles 90027 Call for Information (Investigational Site 0302)
United States California Los Angeles 90048 Call for Information (Investigational Site 0018)
United States California Sacramento 95821 Call for Information (Investigational Site 0020)
United States Colorado Aurora 80045 Call for Information (Investigational Site 0023)
United States District of Columbia Washington, D.C. 20010 Call for Information (Investigational Site 0330)
United States District of Columbia Washington, D.C. 20020 Call for Information (Investigational Site 0337)
United States Florida Jacksonville 32207 Call for Information (Investigational Site 0323)
United States Georgia Thomaston 30286 Call for Information (Investigational Site 0326)
United States Louisiana New Orleans 70115 Call for Information (Investigational Site 0333)
United States Mississippi Jackson 39216 Call for Information (Investigational Site 0328)
United States Missouri Kansas City 64111 Call for Information (Investigational Site 0306)
United States Ohio Toledo 43606 Call for Information (Investigational Site 0096)
United States Oregon Portland 97239 Call for Information (Investigational Site 0336)
United States Texas Houston 77081 Call for Information (Investigational Site 0017)
United States Texas Lytle 78052 Call for Information (Investigational Site 0015)
United States Washington Tacoma 98405 Call for Information (Investigational Site 0342)
Argentina Buenos Aires Merck Sharp & Dohme (Argentina) Inc.
Alfredo Wilkinson
54 11 4796 8200
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
Canada Quebec Kirkland H9H 4M7 Merck Canada
Medical Information Centre Centre d'information medicale Merck Canada Inc.
514-428-8600 / 1-800-567-2594
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
Dominican Republic Santo Domingo Merck Sharp & Dohme
Felipe Arbelaez
(787) 474-8200
Georgia Tbilisi Merck Sharp & Dohme IDEA, Inc.
Eran Gefen
38 (044) 393 74 80
Germany Haar MSD Sharp & Dohme GmbH
German Medical Information Center
49 800 673 673 673
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
Latvia Riga Merck Sharp & Dohme Latvija SIA
Katrin Moeschlin
+46 (0) 8ý578ý135 00
Lithuania Vilnius UAB "Merck Sharp & Dohme"
Katrin Moeschlin
+46 (0) 8ý578ý135 00
Malaysia Petaling Jaya MSD
Boon Hock Yeoh
60 377181723
Mauritius Port Louis Merck Sharp & Dohme Ilaclari Ltd. Sti
Cem Ozesen
90 212 3361260
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
Poland Warsaw MSD Polska Sp. Z o.o.
Thomas Johansson
48 22ý478 43 24
Romania Bucharest Merck Sharp & Dohme Romania SRL
Simona Olaru
38 (044) 393 74 80
Russian Federation Moscow Merck Sharp & Dohme IDEA, Inc.
Tatiana Serebriakova
74959167100, EXT.366
Saudi Arabia Riyadh MSD (IA) Corp - SA Branch
Samer El-Ali
04 4269100
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
Thailand Bangkok MSD (Thailand) Ltd.
Thanu Komolsai
66 2262 5746
United Arab Emirates Dubai Merck Sharp & Dohme
Samer El-Ali
04 4269100

Contact

Toll Free Number
1-888-577-8839

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