Clinical trial NCT04012775: Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
insulin
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Antibody Response
timeFrame: 24 weeks
Secondary outcomes:
measure: Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency
timeFrame: 28 weeks (4 + 24 weeks)
measure: Change in BMI from baseline
timeFrame: 24 weeks
measure: Occurrence of adverse events
timeFrame: 28 weeks (4 + 24 weeks)
measure: Occurrence of Injection Site Reaction
timeFrame: 28 weeks (4 + 24 weeks)
measure: Change in HbA1c from baseline
timeFrame: 24 weeks
measure: Change in fasting plasma glucose level from baseline
timeFrame: 4 weeks
measure: Change in fasting plasma glucose level from baseline
timeFrame: 16 weeks
measure: Change in fasting plasma glucose level from baseline
timeFrame: 28 weeks
measure: Change in basal insulin dose per body weight (U/kg) from baseline
timeFrame: 24 weeks
measure: Change in total basal insulin dose (U) from baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Railway Clinical Hospital
city: Moscow
country: Russian Federation
facility: Moscow Endocrinological Dispensary
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital № 71
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital
city: Petrozavodsk
country: Russian Federation
facility: V.A. Baranov Republic Hospital
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 6
city: Saint Petersburg
country: Russian Federation
facility: City Hospital № 2
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 17
city: Saint Petersburg
country: Russian Federation
facility: Medical Sanitary Unit № 157
city: Saint Petersburg
country: Russian Federation
facility: Institute of Medical Research
city: Saint Petersburg
country: Russian Federation
facility: Research Center Eco-Safety
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Diagnostic Center № 85
city: Samara
country: Russian Federation
facility: Diabetes Center
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital № 3
Study officials:
affiliation: Saint Petersburg State Diagnostic Center № 85
name: Olga A Miroshnichenko, PhD
role: PRINCIPAL_INVESTIGATOR
References: