NCT02735044

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study duration per participant was approximately 58 weeks that consisted of a 2 week screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month comparative safety extension period, and a 4-week post treatment follow up period.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine,300 U/mL	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 \[mmol/L\])
DRUG	Insulin glargine (100 units /mL)	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)
DRUG	Background therapy	Fast-acting mealtime insulin analogs

Timeline

• Start date: 2016-04-14
• Primary completion: 2018-05-31
• Completion: 2018-12-20
• First posted: 2016-04-12
• Last updated: 2022-03-25
• Results posted: 2019-06-19

Locations

107 sites across 24 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Mexico, North Macedonia, Poland, Romania, Russia, Serbia, Spain, Sweden, United Kingdom