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NCT00993473 · ClinicalTrials.gov registry record · Phase 3
6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
A Phase 3 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT00993473 is a Phase 3 study of Type 1 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 125 participants, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT00993473, a Phase 3 study of Type 1 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: * rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia * HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment * percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment * average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability
Conditions Studied
Interventions
- DRUG Insulin lispro
- DRUG Insulin glargine (HOE901)
- DRUG Neutral Protamine Hagedorn (NPH) insulin
Study Locations (20)
Other
- Sanofi-Aventis Investigational Site Number 040001 - Vienna
- Sanofi-Aventis Investigational Site Number 076001 - Brasília
- Sanofi-Aventis Investigational Site Number 076003 - Curitiba
- Sanofi-Aventis Investigational Site Number 076005 - Fortaleza
- Sanofi-Aventis Investigational Site Number 076004 - Fortaleza
- Sanofi-Aventis Investigational Site Number 076002 - Porto Alegre
- Sanofi-Aventis Investigational Site Number 076006 - Rio de Janeiro
- Sanofi-Aventis Investigational Site Number 152002 - Santiago
- Sanofi-Aventis Investigational Site Number 152003 - Santiago
- Sanofi-Aventis Investigational Site Number 152001 - Santiago
- Sanofi-Aventis Investigational Site Number 152004 - Viña del Mar
- Sanofi-Aventis Investigational Site Number 203001 - Olomouc
California
- Sanofi-Aventis Investigational Site Number 840006 - Sacramento
- Sanofi-Aventis Investigational Site Number 840014 - San Diego
Texas
- Sanofi-Aventis Investigational Site Number 840010 - Houston
- Sanofi-Aventis Investigational Site Number 840002 - San Antonio
Colorado
- Sanofi-Aventis Investigational Site Number 840005 - Greenwood Village
Maryland
- Sanofi-Aventis Investigational Site Number 840008 - Baltimore
New York
- Sanofi-Aventis Investigational Site Number 840007 - Buffalo
Pennsylvania
- Sanofi-Aventis Investigational Site Number 840011 - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00993473
The ClinicalTrials.gov registry entry for NCT00993473 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (10% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Insulin lispro is the first listed.
NCT00993473 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT00993473 about?
NCT00993473 is a clinical study titled "6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes". The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed ...
What is the current status of trial NCT00993473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2009-10. Estimated completion is 2011-03.
What conditions does trial NCT00993473 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT00993473?
The interventions under investigation include: Insulin lispro (DRUG), Insulin glargine (HOE901) (DRUG), Neutral Protamine Hagedorn (NPH) insulin (DRUG).
Who is sponsoring clinical trial NCT00993473?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00993473 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, New York, Pennsylvania. 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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