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

Geropharm

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: Insulin Humulin® NPH; Biological: Insulin Rinsulin® NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT04012775

RINPH-IM

Details and patient eligibility

About

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

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Insulin Humulin® NPH

Active Comparator group

Description:

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

Treatment:

Biological: Insulin Humulin® NPH

Insulin Rinsulin® NPH

Experimental group

Description:

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

Treatment:

Biological: Insulin Rinsulin® NPH