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NCT00395512 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
655
Enrollment target

NCT00395512: Completed Phase 3 study, sponsored by Takeda.

NCT00395512 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 655 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00395512, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
655 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

Primary Outcome

The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).

Interventions

  • DRUG Placebo
  • DRUG Pioglitazone
  • DRUG Alogliptin

Trial Details

FieldValue
Enrollment Target 655 participants
Start Date 2006-11
Est. Completion 2008-02
Phase Phase 3
Takeda

408 total trials

What the finished NCT00395512 record still lists

NCT00395512 is an interventional study that assigns participants to a tested intervention. The registered 655 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00395512 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00395512 about?

NCT00395512 is a clinical study titled "Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus". The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

What is the current status of trial NCT00395512?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 655 participants. The study started on 2006-11. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00395512?

The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG), Alogliptin (DRUG).

Who is sponsoring clinical trial NCT00395512?

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

How this trial's enrollment target compares

Where NCT00395512's enrollment target sits among peer trials

655 565th of 2000 higher than 1,434 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00395512, the US trial registry maintained by the National Library of Medicine. NCT00395512 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.