A Phase 3b trial, in type 1 diabetes mellitus, on children who are at least 1 year old to less than 6 years and are given either Lantus (insulin glargine) or Neutral Protamine Hagedorn (NPH) insulin as the medication?.
- Conditions
- Health Condition 1: null- In patients with Type 1 diabetes mellitus insufficiently aged between 1 to 6 years Health Condition 2: E109- Type 1 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000912
- Lead Sponsor
- Sanofi Synthelabo India limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
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
Hypoglycemia unawareness, as determined by the Investigator
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 anti-hyperglycemic oral agent at any time since the diagnosis of diabetes
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event rate of all hypoglycemia during treatment with study drugs, which consists of: CGM glucose 70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values 70 mg/dL (3.9mM), symptomatic hypoglycemia episodes <br/ ><br>Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method vent Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)Timepoint: 6 months