Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sanofi.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
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 |
What the finished NCT00607087 record still lists
NCT00607087 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 1,264-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (77% lower).
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 lists 12 locations in 2 states (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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
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 NCT00607087's enrollment target sits among peer trials
289 26th of 118 higher than 93 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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
-
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
ACTIVE NOT RECRUITING · Phase 4
-
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
ACTIVE NOT RECRUITING · Phase 4
-
Afrezza® Dosing Optimization Study
COMPLETED · Phase 4
-
Sitagliptin Dose Determination Study
COMPLETED · Phase 4
-
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
COMPLETED · Phase 4
-
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06465199 · 289 participants · Phase 1
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
- NCT00775476 · 290 participants · Phase 2
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
- NCT01874197 · 290 participants · NA
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
- NCT04331353 · 290 participants · NA
The Allergen Reduction and Child Health Study (ARCHS)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia