A Five-year, Observational, Non-interventional Follow-up to: 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 (MK-0431-351)

Study identification

• EU PAS number:
  EUPAS4468
• Study ID:
  49810
• Official title and acronym:
  A Five-year, Observational, Non-interventional Follow-up to: 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 (MK-0431-351)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Brazil

  Canada

  Colombia

  Costa Rica

  Guatemala

  Honduras

  Hungary

  Israel

  Italy

  Lithuania

  Malaysia

  Mexico

  Philippines

  Poland

  Romania

  Russian Federation

  United States
• Study description:
  This is a follow-up study of participants who participated in a multinational, placebo-controlled, double-blind, parallel-group study that assessed the safety and efficacy of sitagliptin once daily in pediatric participants (ages 10-17 years, inclusive at initiation of therapy) with T2DM with inadequate glycemic control. The objective is to provide an up to 5-year observational assessment of safety of participants with T2DM who were treated for up to one year with sitagliptin as initial monotherapy in the aforementioned study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme Co. Ltd. Hod Hasharon, Israel, Phone number: 972 9 9539310

Study timelines

Date when funding contract was signed

Actual:23/01/2013

Study start date

Actual:13/09/2013

Data analysis start date

Actual:08/08/2024

Date of final study report

Actual:27/11/2024

Sources of funding

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable