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NCT00046462 · ClinicalTrials.gov registry record · Phase 3

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
240
Enrollment target

NCT00046462: Completed Phase 3 study, sponsored by Sanofi.

NCT00046462 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00046462, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
240 participants
Enrollment target

Study Summary

The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

Interventions

  • DRUG Metformin
  • DRUG Lantus (insulin glargine [rDNA origin] injection)
  • DRUG Thiazolidinedione
  • DRUG Glyburide

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2001-11
Est. Completion 2004-12
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00046462 record still lists

NCT00046462 is an interventional study that assigns participants to a tested intervention. The registered 240 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 (69% lower).

The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.

NCT00046462 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00046462 about?

NCT00046462 is a clinical study titled "Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment". The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

What is the current status of trial NCT00046462?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2001-11. Estimated completion is 2004-12.

What interventions are being tested in trial NCT00046462?

The interventions under investigation include: Metformin (DRUG), Lantus (insulin glargine [rDNA origin] injection) (DRUG), Thiazolidinedione (DRUG), Glyburide (DRUG).

Who is sponsoring clinical trial NCT00046462?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00046462's enrollment target sits among peer trials

240 1273rd of 2000 higher than 710 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 NCT00046462, the US trial registry maintained by the National Library of Medicine. NCT00046462 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.