CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 298 enrolled
Drug / intervention
Sitagliptin 100 mg +3 moredrug
Likely dose
Sitagliptin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02647320
NCT02647320Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

Daiichi Sankyo·interventional·Posted Jan 6, 2016·Updated Feb 25, 2019

In Brief

A Phase 2 clinical trial evaluating Sitagliptin 100 mg, DS-8500a 25mg, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 298 participants across 58 sites in 2 countries.

Detailed Summary

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 6, 2016
Enrollment StartJan 1, 2016
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.5 years ago

Interventions

Sitagliptin 100 mgdrug

Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration

DS-8500a 25mgdrug

DS-8500a 25mg tablet for oral administration

Placebo Tabletdrug

Placebo matching DS-8500a tablet for oral administration

Placebo Capsuledrug

Placebo matching sitagliptin over-capsule for oral administration