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Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus

NCT00760344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2016-06-22

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of SYR-472, once daily (QD), in subjects with type 2 diabetes mellitus who have not achieved glycemic control with diet and exercise, or by taking metformin.

Conditions

Interventions

DRUG

SYR-472

SYR-472 3.125 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.

DRUG

SYR-472

SYR-472 12.5 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.

DRUG

SYR-472

SYR-472 50 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.

DRUG

SYR-472

SYR-472 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.

DRUG

Placebo

SYR-472 placebo-matching tablets, orally, once daily with lifestyle modification and/or metformin therapy for up to 12 weeks.

DRUG

Sitagliptin

Sitagliptin 100 mg, tablets, orally, once daily with lifestyle modification and/or metformin stable dose therapy for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • VP Biological Sciences · 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
2007-03-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
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 NCT00760344 on ClinicalTrials.gov