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NCT00673231 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

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

Completed
Registry status
Phase 3
Development phase
1,240
Enrollment target
20
Study locations

NCT00673231: Completed Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.

NCT00673231 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 1,240 participants, below the 3,920-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00673231, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,240 participants
Enrollment target
20
Study locations

Study Summary

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Primary Outcome

To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dapagliflozin

Study Locations (20)

Other

  • Research Site - Salzburg
  • Research Site - Vienna
  • Research Site - Pleven
  • Research Site - Rousse
  • Research Site - Sofia
  • Research Site - Varna

California

  • Research Site - Fresno
  • Research Site - Greenbrae

Illinois

  • Research Site - Chicago
  • Research Site - Springfield

Texas

  • Research Site - Corpus Christi
  • Research Site - Dallas

Virginia

  • Research Site - Norfolk
  • Research Site - Richmond

Georgia

  • Research Site - Roswell

Indiana

  • Research Site - Indianapolis

Nebraska

  • Research Site - Omaha

Trial Details

FieldValue
Enrollment Target 1,240 participants
Start Date 2008-04
Est. Completion 2011-01
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00673231 record still lists

NCT00673231 is an interventional study that assigns participants to a tested intervention. Its 1,240 participants enrollment target places it among the larger protocols in the corpus, below the 3,920-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (68% lower).

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

NCT00673231 names 20 study sites across 11 states, led by Other, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00673231 about?

NCT00673231 is a clinical study titled "Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin". This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

What is the current status of trial NCT00673231?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,240 participants. The study started on 2008-04. Estimated completion is 2011-01.

What conditions does trial NCT00673231 study?

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

What interventions are being tested in trial NCT00673231?

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

Who is sponsoring clinical trial NCT00673231?

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

Where is trial NCT00673231 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Indiana, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Type 2 Diabetes

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 NCT00673231's enrollment target sits among peer trials

1,240 19th of 327 higher than 309 of 327 other Type 2 Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes 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 NCT00673231, the US trial registry maintained by the National Library of Medicine. NCT00673231 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.