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12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

NCT02647320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2019-02-25

Study results available
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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.

Conditions

Interventions

DRUG

Sitagliptin 100 mg

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

DRUG

DS-8500a 25mg

DS-8500a 25mg tablet for oral administration

DRUG

Placebo Tablet

Placebo matching DS-8500a tablet for oral administration

DRUG

Placebo Capsule

Placebo matching sitagliptin over-capsule for oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647320 on ClinicalTrials.gov