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Original TRDS for trail "A Study of the Safety and Efficacy of MK-0431A in participants aged 10-17 years with Type 2 Diabetes Mellitus." created on Oct 29, 2015


SLCTR Registration Number

SLCTR/2014/036

Date of Registration

24 Dec 2014

The date of last modification

Oct 29, 2015

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Application Summary

Scientific Title of Trial

A Phase III, Multicenter, Double-Blind, Randomized, Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (a Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients aged 10-17 years with Type 2 Diabetes Mellitus.

Public Title of Trial

A Study of the Safety and Efficacy of MK-0431A in participants aged 10-17 years with Type 2 Diabetes Mellitus.

Disease or Health Condition(s) Studied

Type 2 Diabetes Mellitus

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

ClinicalTrials.gov Identifier: NCT01472367, US IND Number: 70,934


Trial Details

What is the research question being addressed?

Is MK-0431A (fixed-dose combination tablet of sitagliptin and metformin) more effective and safer than metformin alone for the treatment of T2DM in patients aged 10-17 years failing metformin monotherapy?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Active

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 3

Intervention(s) planned

Drugs used: 1. MK-0431A (sitagliptin/metformin fixed dose combination: 50/500, 50/850, and 50/1000 mg) 2. Metformin (500, 850, and 1000 mg) 3. Matching placebos

Consenting participants will be randomized into two arms. There will be a 20-week double-blind treatment period.

Arm 1 Regimen: one tablet of MK-0431A and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals.

Arm 2 Regimen: one tablet MK-0431A-placebo and one tablet of metformin, administered twice daily prior to the morning and evening meals.

Open-label insulin will be used as glycemic rescue therapy throughout the 20-week double-blind treatment period. Insulin will be sourced locally and administered subcutaneously based on American Diabetic Association guidelines for the indication and use of insulin

Inclusion criteria

  1. Subjects between the age of 10 to 17 years on day of signing informed consent with randomization to occur prior to 18th birthday.
  2. Diagnosed Type 2 Diabetes Mellitus (T2DM)
  3. Has not received treatment with insulin for at least 12 weeks prior to the Screening Visit/Visit 1.
  4. HbA1C 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, for greater than or equal to 12 weeks. (Participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated).
  5. Participant has a family member or adult closely involved in the daily activities.

Exclusion criteria

  1. Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes).
  2. Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
  3. Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.
  4. Participant has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin,alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide).
  5. Exhibits abnormal growth patterns or is being treated with growth hormone.
  6. History of idiopathic acute pancreatitis or chronic pancreatitis

Primary outcome(s)

1.

Hemoglobin A1c (A1C)

 [

At baseline and at the completion of 20 weeks

]

Secondary outcome(s)

1.

1) Change from baseline in FPG at Week 20 2) Percentage of patients with A1C at goal (<7.0% as primary; <6.5% as secondary) at Week 20 3) Percentage of patients initiating glycemic rescue therapy at Week 20 4) Percentages of patients with symptomatic hypoglycemia 5) Percentages of patients with symptomatic GI events (i.e., nausea, vomiting, abdominal pain or discomfort, and diarrhea)

 [

At baseline and at the completion of 20 weeks

]

Target number/sample size

25 patients from Sri Lanka, 90 patients (Globally)

Countries of recruitment

Argentina, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Germany, Guatemala, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Sri Lanka, Thailand, United Arab Emirates, United Kingdom, United States

Anticipated start date

2014-12-24

Anticipated end date

2017-12-03

Date of first enrollment

Date of study completion

Recruitment status

Recruiting

Funding source

Merck Sharp and Dohme Corp

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Noel Somasundaram
Consultant Endocrinologist
Diabetes and Endocrine Unit National Hospital of Sri Lanka
+9411-2691111-2800
+94 773 660 923

noelsomasundaram@gmail.com

Contact Person for Public Queries

Prof. Asita de Silva
Director
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya Thalagolla Road, Ragama, Sri Lanka
+94 112665266


asita@remediumone.com

Primary study sponsor/organization

Merck Sharp and Dohme Corp

MSD Pharmaceuticals MSD Pharmaceutical Pvt Ltd, 6th Floor, Vatika Tower Sector-54 Gurgaon, Haryana - 122002 India
91-124-4647300


www.msdindia.in

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results