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COMPLETED Phase 3

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

NCT00993473 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 125 participants
Start Date 2009-10
Est. Completion 2011-03
Phase Phase 3

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00993473 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00993473?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial