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NCT00856284 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus

A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
2,639
Enrollment target
20
Study locations

NCT00856284: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Takeda.

NCT00856284 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by Takeda. The registered enrollment target is 2,639 participants, below the 2,940-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856284, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
2,639 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.

Primary Outcome

The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.

Conditions Studied

Interventions

  • DRUG Metformin
  • DRUG Glipizide
  • DRUG Alogliptin

Study Locations (20)

California

  • - Anaheim
  • - Artesia
  • - Chico
  • - Los Alamitos
  • - Mission Viejo
  • - National City
  • - Northridge
  • - Pismo Beach
  • - Riverside
  • - Roseville
  • - Sacramento

Arizona

  • - Mesa
  • - Peoria
  • - Phoenix
  • - Sierra Vista
  • - Tempe
  • - Tucson

Alabama

  • - Montgomery
  • - Muscle Shoals
  • - Pell City

Trial Details

FieldValue
Enrollment Target 2,639 participants
Start Date 2009-03
Est. Completion 2012-10
Phase Phase 3
Takeda

408 total trials

What the finished NCT00856284 record still lists

NCT00856284 is an interventional study that assigns participants to a tested intervention. Its 2,639 participants enrollment target places it among the larger protocols in the corpus, below the 2,940-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (10% lower).

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Metformin is the first listed.

NCT00856284 names 20 study sites across 3 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT00856284 about?

NCT00856284 is a clinical study titled "Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to determine the safety and effectiveness of adding alogliptin, once daily (QD), compared to glipizide with metformin in diabetic patients.

What is the current status of trial NCT00856284?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,639 participants. The study started on 2009-03. Estimated completion is 2012-10.

What conditions does trial NCT00856284 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT00856284?

The interventions under investigation include: Metformin (DRUG), Glipizide (DRUG), Alogliptin (DRUG).

Who is sponsoring clinical trial NCT00856284?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00856284 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00856284's enrollment target sits among peer trials

2,639 8th of 130 higher than 123 of 130 other Type 2 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00856284, the US trial registry maintained by the National Library of Medicine. NCT00856284 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.