MedTrace Logo

Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

NCT00286442 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2012-02-03

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.

Conditions

Interventions

DRUG

Alogliptin and metformin

Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.

DRUG

Alogliptin and metformin

Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.

DRUG

Metformin

Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 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
2006-03-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • Czechia
  • Germany
  • Guatemala
  • Hungary
  • India
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • Poland
  • South Africa
  • United Kingdom

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 NCT00286442 on ClinicalTrials.gov