Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Acarbose Monotherapy
Sponsor: Merck Sharp & Dohme LLC
A PHASE3 clinical study on Type 2 Diabetes Mellitus, this trial is completed. The trial is conducted by Merck Sharp & Dohme LLC and has accumulated 9 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)The study includes an 8-week antihyperglycemic agent (AHA) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.
\*: Wash-off only applicable to patients who were on acarbose and another AHA.
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period\* (which includes a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment period. All participants will receive open-label acarbose at a minimum dose of 50 mg three times daily (t.i.d.) during the run-in and treatment periods.
\*: Wash-off only applicable to patients who were on acarbose and another AHA.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jun 2022 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jun 2022 [monthly]
Completed PHASE3
-
Sep 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 4 earlier versions
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Jun 2018 — Sep 2018 [monthly]
Completed PHASE3
-
Jun 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2017 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jan 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Merck Sharp & Dohme LLC
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.