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

NCT04012775 | Completed Phase 3

• 1 other identifier: RINPH-IM
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus; insulin

Outcome Measures

Primary Outcomes (1)

• Antibody Response

  Change from baseline in titer of antibodies to human insulin

  24 weeks

Secondary Outcomes (10)

• Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency

  28 weeks (4 + 24 weeks)

• Change in BMI from baseline

  24 weeks

• Occurrence of adverse events

  28 weeks (4 + 24 weeks)

• Occurrence of Injection Site Reaction

  28 weeks (4 + 24 weeks)

• Change in HbA1c from baseline

  24 weeks

Study Arms (2)

Insulin Humulin® NPH

ACTIVE COMPARATOR

Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment

Biological: Insulin Humulin® NPH

Insulin Rinsulin® NPH

EXPERIMENTAL

Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment

Biological: Insulin Rinsulin® NPH

Interventions

Insulin Humulin® NPH BIOLOGICAL

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

Insulin Humulin® NPH

Insulin Rinsulin® NPH BIOLOGICAL

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

Insulin Rinsulin® NPH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written consent
• Diabetes mellitus type 2
• Indications for Rinsulin NPH / Humalog NPH treatment
• Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
• Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
• Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.

You may not qualify if:

• Age less than 18 years old at screening
• Pregnant and breast-feeding women
• Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
• Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
• History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
• Presence of severe diabetes complications
• Receipt of another investigational drug in the 3 months prior to screening
• Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
• History or presence of drug abuse
• Positive test for addictive substance in urine at screening

Sponsors & Collaborators

• Geropharm: lead

Study Sites (14)

Chelyabinsk Railway Clinical Hospital

Chelyabinsk, 454000, Russia

Location

Moscow Endocrinological Dispensary

Moscow, 119034, Russia

Location

Moscow Clinical Hospital № 71

Moscow, 121374, Russia

Location

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

V.A. Baranov Republic Hospital

Petrozavodsk, 185000, Russia

Location

City Polyclinic № 6

Saint Petersburg, 192148, Russia

Location

City Hospital № 2

Saint Petersburg, 194354, Russia

Location

City Polyclinic № 17

Saint Petersburg, 195176, Russia

Location

Medical Sanitary Unit № 157

Saint Petersburg, 196066, Russia

Location

Institute of Medical Research

Saint Petersburg, 196084, Russia

Location

Research Center Eco-Safety

Saint Petersburg, 196143, Russia

Location

Saint Petersburg State Diagnostic Center № 85

Saint Petersburg, 198260, Russia

Location

Diabetes Center

Samara, 443067, Russia

Location

Clinical Hospital № 3

Yaroslavl, 150007, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Olga A Miroshnichenko, PhD

  Saint Petersburg State Diagnostic Center № 85

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: April 20, 2017
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)