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NCT00885378 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
166
Enrollment target

NCT00885378: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00885378 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00885378, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
166 participants
Enrollment target

Study Summary

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Primary Outcome

Mean change was adjusted for baseline.

Interventions

  • DRUG Saxagliptin plus metformin IR
  • DRUG Placebo plus metformin IR

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2009-05
Est. Completion 2010-02
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00885378 record still lists

NCT00885378 is an interventional study that assigns participants to a tested intervention. The registered 166 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 (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Saxagliptin plus metformin IR is the first listed.

NCT00885378 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00885378 about?

NCT00885378 is a clinical study titled "Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus". The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

What is the current status of trial NCT00885378?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2009-05. Estimated completion is 2010-02.

What interventions are being tested in trial NCT00885378?

The interventions under investigation include: Saxagliptin plus metformin IR (DRUG), Placebo plus metformin IR (DRUG).

Who is sponsoring clinical trial NCT00885378?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00885378's enrollment target sits among peer trials

166 1463rd of 2000 higher than 536 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 NCT00885378, the US trial registry maintained by the National Library of Medicine. NCT00885378 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.