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Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

NCT00286429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2012-02-03

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

Conditions

Interventions

DRUG

Alogliptin and insulin

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

DRUG

Alogliptin and insulin

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

DRUG

Insulin

Alogliptin placebo-matching tablets, orally, once daily and insulin 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
2006-02-28
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

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

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 NCT00286429 on ClinicalTrials.gov