6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

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
    

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 CGMS hypoglycemic excursions <0.5 or ≥0.5
      events per 24 hours). Following randomization, trial basal insulin was initiated and
      up-titrated within the first 12 weeks to reach a stable dose.

      Follow-up phase: 2 weeks

      All Phases: 28 to 30 weeks
    

Intervention name(s): Insulin glargine (HOE901); Neutral Protamine Hagedorn (NPH) insulin; Insulin lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U
Dose: titrated to achieve the following glycemic targets without hypoglycemia:
Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0 mmol/L), inclusive,
Bedtime BG between 120 and 180 mg/dL (6.7 to10.0 mmol/L), inclusive,
Nocturnal BG between 80 and 162 mg/dL (4.4 to 9.0 mmol/L), inclusive; and
HbA1c <7.5%.; NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U
Dose: titrated to achieve glycemic targets as described above for insulin glargine; Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator.
Other intervention name(s): Lantus®; Humalog®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment