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

• Sponsor: Geropharm (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04012775
• Collaborator: (none)
• Enrollment: 201
• Locations: 14
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site: 14.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Biological: Insulin Humulin® NPH; Biological: Insulin Rinsulin® NPH	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 20, 2017
• Actual Primary Completion Date: Sep 24, 2018
• Actual Study Completion Date: Sep 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Insulin Humulin® NPH 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; 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Experimental: Insulin Rinsulin® NPH 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; 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

Outcome Measures

Primary Outcome Measures

1. Antibody Response [24 weeks]

   Change from baseline in titer of antibodies to human insulin

Secondary Outcome Measures

1. Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency [28 weeks (4 + 24 weeks)]

2. Change in BMI from baseline [24 weeks]

3. Occurrence of adverse events [28 weeks (4 + 24 weeks)]

4. Occurrence of Injection Site Reaction [28 weeks (4 + 24 weeks)]

5. Change in HbA1c from baseline [24 weeks]

6. Change in fasting plasma glucose level from baseline [4 weeks]

7. Change in fasting plasma glucose level from baseline [16 weeks]

8. Change in fasting plasma glucose level from baseline [28 weeks]

9. Change in basal insulin dose per body weight (U/kg) from baseline [24 weeks]

10. Change in total basal insulin dose (U) from baseline [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chelyabinsk Railway Clinical Hospital	Chelyabinsk		Russian Federation	454000
2	Moscow Endocrinological Dispensary	Moscow		Russian Federation	119034
3	Moscow Clinical Hospital № 71	Moscow		Russian Federation	121374
4	Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod		Russian Federation	603126
5	V.A. Baranov Republic Hospital	Petrozavodsk		Russian Federation	185000
6	City Polyclinic № 6	Saint Petersburg		Russian Federation	192148
7	City Hospital № 2	Saint Petersburg		Russian Federation	194354
8	City Polyclinic № 17	Saint Petersburg		Russian Federation	195176
9	Medical Sanitary Unit № 157	Saint Petersburg		Russian Federation	196066
10	Institute of Medical Research	Saint Petersburg		Russian Federation	196084
11	Research Center Eco-Safety	Saint Petersburg		Russian Federation	196143
12	Saint Petersburg State Diagnostic Center № 85	Saint Petersburg		Russian Federation	198260
13	Diabetes Center	Samara		Russian Federation	443067
14	Clinical Hospital № 3	Yaroslavl		Russian Federation	150007

Sponsors and Collaborators

• Geropharm

Investigators

• Principal Investigator: Olga A Miroshnichenko, PhD, Saint Petersburg State Diagnostic Center № 85

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geropharm
• ClinicalTrials.gov Identifier: NCT04012775
• Other Study ID Numbers: RINPH-IM
• First Posted: Jul 9, 2019
• Last Update Posted: Jul 9, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Geropharm: diabetes mellitus; insulin
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Jul 9, 2019