Phase 3 N=125 Randomized Treatment

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

Type 1 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00993473 ↗

Enrolled (actual)

125

Serious AEs

8.0%

Results posted

Jun 2012

Primary outcome: Primary: Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) — 192.75; 168.91 number of events per patient-year

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Insulin glargine (HOE901) (Drug); Neutral Protamine Hagedorn (NPH) insulin (Drug); Insulin lispro (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)	192.75; 168.91	—
SECONDARY Event 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)	25.54; 33.02	—
SECONDARY Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years	0.14; 0.07	—
SECONDARY Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of "All Hypoglycemia" Episodes Divided by the Total Duration of the On-treatment Period in Years	33.50; 30.92	—
SECONDARY Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years	2.38; 3.65	—
SECONDARY Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years	0.04; 0.00	—
SECONDARY Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment	8.023; 8.248; 8.071; 8.344; 0.036; 0.000	—
SECONDARY Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)	8.139; 8.232; -0.048; 0.045	—
SECONDARY Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit	22.0; 22.8	—
SECONDARY Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment	11.263; 11.170; 11.085; 11.712; -0.218; 0.501	—

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

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00993473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.