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Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

NCT04012775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2019-07-09

No results posted yet for this study

Summary

The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BIOLOGICAL

Insulin Humulin® NPH

4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

BIOLOGICAL

Insulin Rinsulin® NPH

4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Olga A Miroshnichenko, PhD · Saint Petersburg State Diagnostic Center № 85

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2018-09-24
Completion
2018-09-24

Countries

  • Russia

Study Locations

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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 NCT04012775 on ClinicalTrials.gov