At a glance
ClinicalIndex Comparison Record- ✓Children and adolescents with confirmed type 1 diabetes mellitus (T1DM) for at least 1 year, confirmed by typical symptoms and/or antibody testing (anti-GAD, anti-IA2, or anti-islet cell antibodies) and/or clinical features
- ✓Age 6 to 17 years at randomization
- ✓At least 6 months on basal-bolus insulin (basal plus mealtime) with self-monitoring of blood glucose prior to screening
- ✓HbA1c between 7.5% and 11% at screening
- ✕Less than 1 year on insulin treatment prior to screening
- ✕Use of premix insulins in the last 3 months before screening or use of human regular insulin as mealtime insulin in the last 3 months before screening
- ✕Use of an insulin pump in the last 6 months before screening or plans to switch to pump within the next 6 months after screening
- ✕Contraindication to use of insulin glargine as defined in the national product label
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
In Brief
A Phase 3 clinical trial evaluating Insulin glargine,300 U/mL, Insulin glargine (100 units /mL), and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 463 participants across 107 sites in 24 countries.
Detailed Summary
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: * Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). * To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
Study Details
Timeline
Interventions
Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter \[mmol/L\])
Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L)
Fast-acting mealtime insulin analogs