NCT04022993

Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin RinGlar® ("Geropharm", Russia) Compared to Lantus® SoloStar® ("Sanofi-Aventis Deutschland GmbH", Germany) in Type 1 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Geropharm · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Lantus Solostar, 100 Units/mL Subcutaneous Solution	4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
DRUG	Insulin RinGlar, 100 Units/mL Subcutaneous Solution	4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Timeline

• Start date: 2018-07-04
• Primary completion: 2019-02-25
• Completion: 2019-05-15
• First posted: 2019-07-17
• Last updated: 2019-07-17

Locations

14 sites across 1 country: Russia