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

NCT04022993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-07-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Tatyana L Karonova, MD, DSc · Almazov National Medical Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-04
Primary Completion
2019-02-25
Completion
2019-05-15

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022993 on ClinicalTrials.gov