Status:
COMPLETED
6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Screening phase: 2 to 4 weeks Treatment phase: 24 weeks At randomization, patients were stratified with respect to their baseline HbA1c level (\<8.5% or ≥8.5%) and hypoglycemic event rate (number of...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
- Exclusion criteria:
- Diagnosis of type 1 diabetes for less than one year
- HbA1c at screening \>12% or \<6%
- Diabetes other than type 1 diabetes
- Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
- Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
- Patients treated with insulin pump therapy during the two months prior to screening
- History of primary seizure disorder
- History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
- Need for chronic treatment with acetaminophen (paracetamol)-containing medications
- Serum creatinine \> 2.0mg/dL at screening
- Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening
- Hemoglobin \< 10g/dL, or platelet count less than 100,000/cu mm, at screening
- Treatment with any pharmacologic anti-hyperglycemic oral agent for more than 3 months at any time
- Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening
- Treatment with systemic glucocorticoids within the month prior to screening
- Above information not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00993473
Start Date
October 1 2009
End Date
March 1 2011
Last Update
June 27 2012
Active Locations (61)
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1
Sanofi-Aventis Investigational Site Number 840006
Sacramento, California, United States, 95819
2
Sanofi-Aventis Investigational Site Number 840014
San Diego, California, United States, 92123
3
Sanofi-Aventis Investigational Site Number 840005
Greenwood Village, Colorado, United States, 80111
4
Sanofi-Aventis Investigational Site Number 840008
Baltimore, Maryland, United States, 21229