Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus

NCT00763347 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-05-21

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of SYR-619, 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-619

SYR-619 12.5 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

SYR-619

SYR-619 50 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

SYR-619

SYR-619 100 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

SYR-619

SYR-619 200 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Placebo

SYR-619 placebo-matching tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily 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
2006-11-30
Primary Completion
2007-02-28
Completion
2007-02-28

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Entities

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 NCT00763347 on ClinicalTrials.gov