A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
Overview
- Phase
- Phase 3
- Intervention
- Insulin glargine (HOE901)
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 162
- Locations
- 10
- Primary Endpoint
- Absolute change of glycosylated hemoglobin (HbA1c)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 (T1DM) aged at least 6 years to less than 18 years.
Secondary Objectives:
-
To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:
- Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
- Fasting blood glucose (FBG),
- Nocturnal blood glucose (BG),
- 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
- Daily total insulin dose and basal insulin dose,
- Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
-
To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
-
To assess anti-insulin and anti-glargine antibody development in both groups.
-
To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Insulin glargine
injection once daily at bedtime
Intervention: Insulin glargine (HOE901)
NPH insulin
injection once daily at bedtime or twice daily in the morning and at bedtime
Intervention: NPH insulin
Outcomes
Primary Outcomes
Absolute change of glycosylated hemoglobin (HbA1c)
Time Frame: from baseline to week 24
Secondary Outcomes
- Anti-glargine and anti-human insulin antibody assessment(at screening, week 4, week 24)
- Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)(from baseline to week 24)
- Change in total insulin dose and basal insulin dose(from baseline to week 24)
- Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.(during 24-week treatment period)
- Change in nocturnal Blood Glucose (BG)(from baseline to week 24)
- Change in Fasting Blood Glucose (FBG)(from baseline to week 24)
- Percentage of patients reaching HbA1c < 7.5%(at week 24)