Study to Assess Safety & Efficacy of Sitagliptin as Initial Monotherapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants (MK-0431-083)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01485614
First received: December 1, 2011
Last updated: July 23, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Diabetes Mellitus
Type 2 Diabetes
Drug: Sitagliptin
Drug: Metformin
Drug: Placebo to sitagliptin
Drug: Placebo to metformin
Drug: Metformin Rescue
Drug: Sitagliptin Rescue
Biological: Insulin Rescue
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in A1C [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events (AE) [ Time Frame: Up to 56 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study medication due to an AE [ Time Frame: Up to 54 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in A1C at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Percentage of participants with an A1C target of <7.0%, <6.5% at Week 20 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Percentage of participants with an A1C target of <7.0%, <6.5% at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in proinsulin at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in proinsulin at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in proinsulin/insulin ratio at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in proinsulin/insulin ratio at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in Homeostatic Model Assessment of β-cell function (HOMA-β) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in HOMA-β at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in Homeostatic Model Assessment of insulin resistance (HOMA-IR) at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in HOMA-IR at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in endpoints at 2 hours after the start of the meal for 2-hour PMG and 2-hour incremental PMG at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in endpoints at 2 hours after the start of the meal for 2-hour PMG and 2-hour incremental PMG at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in AUC endpoints (Total AUC and Excursion AUC) for glucose, insulin, C-peptide, proinsulin, proinsulin AUC/Insulin AUC, Insulin AUC/ Glucose AUC at Week 20 [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
  • Change from baseline in AUC endpoints (Total AUC and Excursion AUC) for glucose, insulin, C-peptide, proinsulin, proinsulin AUC/Insulin AUC, Insulin AUC/ Glucose AUC at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Proportion of patients requiring glycemic rescue therapy at Week 20 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Proportion of patients requiring glycemic rescue therapy at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: February 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin 100 mg oral tablet once a day and placebo to metformin oral tablet (500 mg), 2 tablets twice daily prior to morning and evening meals for 20 weeks (Phase A). Participants who have not initiated glycemic rescue therapy will continue to receive Phase A treatment during Phase B (34 weeks).
Drug: Sitagliptin
100 mg oral tablet of sitagliptin prior to the morning meal in Phase A and Phase B.
Other Name: Januvia
Drug: Placebo to sitagliptin
After randomization: Participants randomized to the Placebo Phase A/Metformin Phase B arm will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the Placebo Phase A/Metformin Phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. For 1 week, participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal.
Drug: Placebo to metformin
After randomization: Participants randomized to the Sitagliptin Arm and those randomized to the Placebo Phase A/Metformin Phase B arm will receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. Phase B: Participants in the Sitagliptin Arm will continue to receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. For 1 week participants will receive oral tablets of placebo to metformin (500 mg), 2 tablets prior to the morning and evening meals.
Drug: Metformin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving sitagliptin or placebo (in Phase A), or sitagliptin (in Phase B) will initiate metformin.
Drug: Sitagliptin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving metformin (in Phase B) will initiate sitagliptin.
Biological: Insulin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 2 (open-label), participants receiving sitagliptin, placebo or metformin will receive insulin according to routine clinical practice.
Active Comparator: Metformin
Metformin (500 mg) oral tablets, 2 tablets twice daily prior to morning and evening meals and placebo to sitagliptin (100 mg), oral tablet once daily for 20 weeks (Phase A). Participants who have not initiated glycemic rescue therapy will continue to receive Phase A treatment for 34 weeks (Phase B). This arm of the study was removed by a protocol amendment.
Drug: Metformin
Metformin (500 mg), 2 tablets twice daily prior to morning and evening meals
Other Name: Glucophage
Drug: Placebo to sitagliptin
After randomization: Participants randomized to the Placebo Phase A/Metformin Phase B arm will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the Placebo Phase A/Metformin Phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. For 1 week, participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal.
Drug: Placebo to metformin
After randomization: Participants randomized to the Sitagliptin Arm and those randomized to the Placebo Phase A/Metformin Phase B arm will receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. Phase B: Participants in the Sitagliptin Arm will continue to receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. For 1 week participants will receive oral tablets of placebo to metformin (500 mg), 2 tablets prior to the morning and evening meals.
Drug: Metformin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving sitagliptin or placebo (in Phase A), or sitagliptin (in Phase B) will initiate metformin.
Drug: Sitagliptin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 1 (blinded), eligible participants receiving metformin (in Phase B) will initiate sitagliptin.
Biological: Insulin Rescue
Mandatory glycemic rescue will be initiated in both Phase A and Phase B for participants meeting defined glycemic thresholds. For Rescue Step 2 (open-label), participants receiving sitagliptin, placebo or metformin will receive insulin according to routine clinical practice.
Experimental: Placebo Phase A/Sitagliptin B
Placebo to sitagliptin oral tablet once a day and placebo to metformin oral tablets (500 mg), 2 tablets twice daily prior to morning and evening meals for 20 weeks (Phase A). Participants who have not initiated glycemic rescue therapy will receive 1 tablet of sitagliptin daily and 2 tablets of metformin placebo twice daily prior to morning and evening meals (Phase B). This arm of the study was removed by a protocol amendment.
Drug: Sitagliptin
100 mg oral tablet of sitagliptin prior to the morning meal in Phase A and Phase B.
Other Name: Januvia
Drug: Placebo to sitagliptin
After randomization: Participants randomized to the Placebo Phase A/Metformin Phase B arm will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the Placebo Phase A/Metformin Phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. For 1 week, participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal.
Drug: Placebo to metformin
After randomization: Participants randomized to the Sitagliptin Arm and those randomized to the Placebo Phase A/Metformin Phase B arm will receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. Phase B: Participants in the Sitagliptin Arm will continue to receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. For 1 week participants will receive oral tablets of placebo to metformin (500 mg), 2 tablets prior to the morning and evening meals.
Experimental: Placebo Phase A / Metformin Phase B
Placebo to sitagliptin oral tablet once a day and placebo to metformin oral tablets (500 mg), 2 tablets twice daily prior to morning and evening meals for 20 weeks (Phase A). Participants who have not initiated glycemic rescue therapy will receive 1 tablet of sitagliptin-placebo daily and metformin oral tablets (500 mg), 2 tablets twice daily prior to morning and evening meals during Phase B (34 weeks).
Drug: Metformin
Metformin (500 mg), 2 tablets twice daily prior to morning and evening meals
Other Name: Glucophage
Drug: Placebo to sitagliptin
After randomization: Participants randomized to the Placebo Phase A/Metformin Phase B arm will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. Phase B: Participants in the Placebo Phase A/Metformin Phase B arm will continue to receive 1 oral tablet of placebo to sitagliptin prior to the morning meal. For 1 week, participants will receive 1 oral tablet of placebo to sitagliptin prior to the morning meal.
Drug: Placebo to metformin
After randomization: Participants randomized to the Sitagliptin Arm and those randomized to the Placebo Phase A/Metformin Phase B arm will receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. Phase B: Participants in the Sitagliptin Arm will continue to receive 2 oral tablets of placebo to metformin prior to the morning and evening meals. For 1 week participants will receive oral tablets of placebo to metformin (500 mg), 2 tablets prior to the morning and evening meals.

Detailed Description:

This trial is of approximately 56 weeks in duration, including a screening period of up to 1 week, a 1-week single-blind placebo run-in period, a 20-week placebo-controlled, double blind treatment period [Phase A] and a 34-week double-blind active controlled treatment period [Phase B] during which participants randomized to the placebo arm who have not initiated glycemic rescue therapy with metformin during Phase A will receive metformin (in a blinded manner). A telephone contact will be performed 14 days after the last dose of study medication to assess for any serious adverse events (SAEs).

Two arms of the study were removed from the study by a protocol amendment.

  Eligibility

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

Inclusion Criteria:

  • Type 2 Diabetes Mellitus (T2DM)
  • Has not received treatment with an oral antihyperglycemic agent (AHA) or insulin for ≥12 weeks prior to the Screening Visit/Visit 1.
  • An A1C of ≥6.5% 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.
  • 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: NCT01485614

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

  Hide Study Locations
Locations
United States, Alabama
Call for Information (Investigative Site 0312) Recruiting
Birmingham, Alabama, United States, 35233-1711
Call for Information (Investigational Site 0312) Recruiting
Birmingham, Alabama, United States, 35233-1711
United States, Arizona
Call for Information (Investigational Site 0316) Recruiting
Phoenix, Arizona, United States, 85048
Call for Information (Investigational Site 0317) Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Call for Information (Investigational Site 0012) Recruiting
Canoga Park, California, United States, 91303
Call for Information (Investigational Site 0013) Recruiting
Clovis, California, United States, 93612
Call for Information (Investigational Site 0018) Recruiting
Los Angeles, California, United States, 90048
Call for Information (Investigational Site 0020) Recruiting
Sacramento, California, United States, 95821
Call for Information (Investigational Site 0019) Recruiting
San Diego, California, United States, 92123
Call for Information (Investigational Site 0334) Recruiting
San Diego, California, United States, 92102
Call for Information (Investigational Site 0307) Recruiting
Ventura, California, United States, 93003
United States, Colorado
Call for Information (Investigational Site 0023) Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Call for Information (Investigational Site 0320) Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Call for Information (Investigational Site 0325) Recruiting
Atlanta, Georgia, United States, 30342
Call for Information (Investigational Site 0326) Recruiting
Thomaston, Georgia, United States, 30286
United States, Kentucky
Call for Information (Investigational Site 0303) Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Call for Information (Investigational Site 0333) Recruiting
New Orleans, Louisiana, United States, 70115
United States, Maine
Call for Information (Investigational Site 0009) Recruiting
Portland, Maine, United States, 04102
United States, Maryland
Call for Information (Investigational Site 0305) Recruiting
Baltimore, Maryland, United States, 21215
United States, New Jersey
Call for Information (Investigational Site 0309) Recruiting
Neptune, New Jersey, United States, 07753
United States, New York
Call for Information (Investigational Site 0310) Recruiting
Lake Success, New York, United States, 11042
United States, Ohio
Call for Information (Investigational Site 0014) Recruiting
Akron, Ohio, United States, 44308
Call for Information (Investigational Site 0090) Recruiting
Canal Fulton, Ohio, United States, 44614
Call for Information (Investigational Site 0096) Recruiting
Toledo, Ohio, United States, 43606
United States, Tennessee
Call for Information (Investigational Site 0324) Recruiting
Lebanon, Tennessee, United States, 37087
United States, Texas
Call for Information (Investigational Site 0015) Recruiting
Boerne, Texas, United States, 78006
Call for Information (Investigational Site 0322) Recruiting
Edinburg, Texas, United States, 78539
Call for Information (Investigational Site 0017) Recruiting
Houston, Texas, United States, 77081
Call for Information (Investigational Site 0006) Recruiting
San Antonio, Texas, United States, 78229
Argentina
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz    61 2 8988 8246      
Austria
MSD Osterreich GmbH Recruiting
Vienna, Austria
Contact: Karl Boegl    43 126044130      
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      
Denmark
Merck Sharp & Dohme Recruiting
Glostrup, Denmark
Contact: Gert Andersen    45 44824475      
Dominican Republic
Merck Sharp & Dohme Recruiting
Santo Domingo, Dominican Republic
Contact: Felipe Arbelaez    (787) 474-8200      
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
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      
Hungary
MSD Pharma Hungary Kft. Recruiting
Budapest, Hungary
Contact: Simona Martinkova    36 1 457 8522      
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      
Panama
MSD CARD Recruiting
Panama, Panama
Contact: Soraya Cedraro    507-282-7200      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Adam Czernik    48 22 4784324      
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      
Slovakia
Merck Sharp Dohme S.R.O. Recruiting
Bratislava, Slovakia
Contact: Eva Kaszasova    420 233010213      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez    34 913210600      
Sweden
MSD Recruiting
Sollentuna, Sweden
Contact: Tryggve Ljung    46 (0)70 545 28 66      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Thanu Komolsai    66 2262 5746      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01485614     History of Changes
Other Study ID Numbers: 0431-083
Study First Received: December 1, 2011
Last Updated: July 23, 2014
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
Insulin
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 July 23, 2014