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Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

NCT01023581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2013-03-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Alogliptin

Alogliptin tablets.

DRUG

Metformin

Metformin capsules

DRUG

Alogliptin Placebo

Alogliptin placebo-matching tablets.

DRUG

Metformin Placebo

Metformin placebo-matching capsules.

Sponsors & Collaborators

Principal Investigators

  • Vice President, Clinical Science · 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
2009-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • Czechia
  • Hungary
  • Israel
  • Lithuania
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01023581 on ClinicalTrials.gov