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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012775
• Other study ID #: RINPH-IM
• Status: Completed
• Phase: Phase 3
• Start date: April 20, 2017
• Est. completion date: September 24, 2018

Study information

• Verified date: January 2019
• Source: Geropharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• Insulin Humulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
• Insulin Rinsulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Railway Clinical Hospital	Chelyabinsk
Russian Federation	Moscow Clinical Hospital ? 71	Moscow
Russian Federation	Moscow Endocrinological Dispensary	Moscow
Russian Federation	Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod
Russian Federation	V.A. Baranov Republic Hospital	Petrozavodsk
Russian Federation	City Hospital ? 2	Saint Petersburg
Russian Federation	City Polyclinic ? 17	Saint Petersburg
Russian Federation	City Polyclinic ? 6	Saint Petersburg
Russian Federation	Institute of Medical Research	Saint Petersburg
Russian Federation	Medical Sanitary Unit ? 157	Saint Petersburg
Russian Federation	Research Center Eco-Safety	Saint Petersburg
Russian Federation	Saint Petersburg State Diagnostic Center ? 85	Saint Petersburg
Russian Federation	Diabetes Center	Samara
Russian Federation	Clinical Hospital ? 3	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Geropharm

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Response	Change from baseline in titer of antibodies to human insulin	24 weeks
Secondary	Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency		28 weeks (4 + 24 weeks)
Secondary	Change in BMI from baseline		24 weeks
Secondary	Occurrence of adverse events		28 weeks (4 + 24 weeks)
Secondary	Occurrence of Injection Site Reaction		28 weeks (4 + 24 weeks)
Secondary	Change in HbA1c from baseline		24 weeks
Secondary	Change in fasting plasma glucose level from baseline		4 weeks
Secondary	Change in fasting plasma glucose level from baseline		16 weeks
Secondary	Change in fasting plasma glucose level from baseline		28 weeks
Secondary	Change in basal insulin dose per body weight (U/kg) from baseline		24 weeks
Secondary	Change in total basal insulin dose (U) from baseline		24 weeks