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NCT00607087 · ClinicalTrials.gov registry record · Phase 4
Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
A Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 289
- Enrollment target
- 12
- Study locations
NCT00607087 is a Phase 4 study of Diabetes Mellitus, Type 1 that has completed, run by Sanofi. The registered enrollment target is 289 participants, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower). The trial reports 12 study locations across 2 states.
The verdict
NCT00607087, a Phase 4 study of Diabetes Mellitus, Type 1, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 289 participants
- Enrollment target
- 12
- Study locations
Study Summary
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. Main Secondary objectives: To compare insulin glulisine, insulin aspart and insulin lispro on: * Unexplained hyperglycemia * Infusion set occlusion * Hypoglycemic episodes,7-point blood glucose profiles * Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis * Time to change the infusion set * HbA1c (Glycosylated hemoglobin) * Overall safety: incidence of adverse events
Conditions Studied
Interventions
- DRUG Insulin aspart
- DRUG Insulin lispro
- DRUG Insulin glulisine
Study Locations (12)
Other
- Sanofi-Aventis Administrative Office - Macquarie Park
- Sanofi-Aventis Administrative Office - Vienna
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Netanya
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - PE Gouda
- Sanofi-Aventis Administrative Office - Seoul
- Sanofi-Aventis Administrative Office - Barcelona
- Sanofi-Aventis Administrative Office - Bromma
- Sanofi-Aventis Administrative Office - Guildford Surrey
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00607087
The ClinicalTrials.gov registry entry for NCT00607087 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Insulin aspart is the first listed.
NCT00607087 reports 12 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00607087 about?
NCT00607087 is a clinical study titled "Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus". Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. Main Secondary objectives: To compare insulin glulisine, insulin aspart and insulin lispro...
What is the current status of trial NCT00607087?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 289 participants. The study started on 2008-01. Estimated completion is 2009-06.
What conditions does trial NCT00607087 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT00607087?
The interventions under investigation include: Insulin aspart (DRUG), Insulin lispro (DRUG), Insulin glulisine (DRUG).
Who is sponsoring clinical trial NCT00607087?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00607087 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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