Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01760447
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE February 17, 2013
Actual Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01760447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Efficacy of MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-289)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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 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: 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Sitagliptin + Metformin XR FDC
    • Drug: Placebo to metformin XR
    • Drug: Insulin glargine
    • Biological: Background insulin
  • 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.
    Interventions:
    • Drug: Placebo to Sitagliptin + Metformin XR
    • Drug: Metformin XR
    • Drug: Insulin glargine
    • Biological: Background insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
101
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
240
Actual Study Completion Date  ICMJE September 15, 2019
Actual Primary Completion Date September 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Costa Rica,   Czech Republic,   Denmark,   Georgia,   Greece,   Guatemala,   Honduras,   Hungary,   Israel,   Italy,   Mauritius,   Mexico,   Moldova, Republic of,   Netherlands,   New Zealand,   Panama,   Philippines,   Russian Federation,   Saudi Arabia,   Serbia,   South Africa,   Sri Lanka,   Taiwan,   Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT01760447
Other Study ID Numbers  ICMJE 0431A-289
2012-004035-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP