Status:
COMPLETED
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Primary Objective: 6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1...
Detailed Description
The study duration for each patient is 28 weeks +/- 7 day broken down as follows: * Screening phase: up to 2 weeks * Run-in phase: 1 week * Treatment phase: 24 weeks * Follow-up: 1 week
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.
- Exclusion criteria:
- Treatment with oral or parenteral glucose-lowering medications other than insulin.
- HbA1c \< 7% or \> 12 % at screening.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01223131
Start Date
February 1 2011
End Date
March 1 2014
Last Update
April 1 2014
Active Locations (10)
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1
Investigational Site Number 156006
Beijing, China, 100020
2
Investigational Site Number 156001
Beijing, China, 100045
3
Investigational Site Number 156007
Beijing, China, 100730
4
Investigational Site Number 156009
Changsha, China, 410011