MedTrace Logo

Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes

NCT01890122 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2016-11-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).

Conditions

Interventions

DRUG

Alogliptin

Alogliptin tablets

DRUG

Metformin HCl

Metformin HCl capsules

DRUG

Alogliptin and Metformin Fixed-Dose Combination (FDC)

Alogliptin and metformin FDC tablets

DRUG

Alogliptin Placebo

Alogliptin placebo-matching tablets

DRUG

Metformin Placebo

Metformin placebo-matching capsules

DRUG

Alogliptin and Metformin FDC Placebo

Alogliptin and metformin FDC placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • China
  • Malaysia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT01890122 on ClinicalTrials.gov