deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT01485614

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

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

Sponsor: Merck Sharp & Dohme LLC

Conditions Diabetes Mellitus Type 2 Diabetes
Interventions Glycemic Rescue 1 Glycemic Rescue 2 Metformin Placebo to metformin Placebo to sitagliptin Sitagliptin
Updated 20 times since 2017 Last updated: Sep 9, 2022 Started: Feb 10, 2012 Primary completion: Oct 9, 2019 Completion: Oct 9, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01485614, this PHASE3 trial focuses on Diabetes Mellitus and Type 2 Diabetes and remains completed. Sponsored by Merck Sharp & Dohme LLC, it has been updated 20 times since 2012, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Apr 2017 · 31 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Apr 2019 · 7 months · monthly snapshot~Apr 2019 – ~Dec 2019 · 8 months · monthly snapshot~Dec 2019 – ~May 2020 · 5 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Jun 2022 · 12 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

20 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2022 — Sep 2022 [monthly]

    Completed PHASE3

  5. Jun 2021 — Jun 2022 [monthly]

    Completed PHASE3

▶ Show 15 earlier versions

  1. Jan 2021 — Jun 2021 [monthly]

    Completed PHASE3

  2. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

  3. Dec 2019 — May 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Apr 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  6. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  7. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  8. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  9. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  10. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  11. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  12. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  13. Mar 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  14. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  15. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Feb 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck Sharp & Dohme LLC
Data source: Merck Sharp & Dohme LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.