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Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus

NCT01414920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2016-04-04

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus (T2DM).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

TAK-875 and sitagliptin placebo-matching tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-875

TAK-875 25 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-875

TAK-875 50 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Sitagliptin

Sitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-875 and Sitagliptin

TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-875 and Sitagliptin

TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Sr. Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01414920 on ClinicalTrials.gov