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NCT00279201 · ClinicalTrials.gov registry record · Phase 4

The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

A Phase 4 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 4
Development phase
2,091
Enrollment target

NCT00279201: Completed Phase 4 study, sponsored by Eli Lilly and Company.

NCT00279201 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 2,091 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (304% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00279201, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 4
Development phase
2,091 participants
Enrollment target

Study Summary

This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.

Interventions

  • DRUG Insulin glargine
  • DRUG Lispro
  • DRUG Lispro Low Mix
  • DRUG Lispro Mid Mix

Trial Details

FieldValue
Enrollment Target 2,091 participants
Start Date 2005-12
Est. Completion 2009-11
Phase Phase 4
Eli Lilly and Company

1,341 total trials

What the finished NCT00279201 record still lists

NCT00279201 is an interventional study that assigns participants to a tested intervention. Its 2,091 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (304% higher).

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

NCT00279201 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00279201 about?

NCT00279201 is a clinical study titled "The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)". This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time...

What is the current status of trial NCT00279201?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,091 participants. The study started on 2005-12. Estimated completion is 2009-11.

What interventions are being tested in trial NCT00279201?

The interventions under investigation include: Insulin glargine (DRUG), Lispro (DRUG), Lispro Low Mix (DRUG), Lispro Mid Mix (DRUG).

Who is sponsoring clinical trial NCT00279201?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00279201's enrollment target sits among peer trials

2,091 34th of 2000 higher than 1,967 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00279201, the US trial registry maintained by the National Library of Medicine. NCT00279201 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.