MedTrace Logo

Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

NCT00755846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2012-02-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes.

Conditions

Interventions

DRUG

Alogliptin

Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks

DRUG

Alogliptin

Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Alogliptin

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

DRUG

Placebo

Alogliptin placebo-matching 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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-10-31
Completion
2005-10-31

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 NCT00755846 on ClinicalTrials.gov