Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® 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 GP40081 (OOO "GEROPHARM", Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226105
• Other study ID #: GP40081-P4-31
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 20, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: January 2020
• Source: Geropharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 264
• Est. completion date: December 25, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed written consent

• Diabetes mellitus type 2 for at least 6 months before the screening (WHO criteria 1999-2013).

• Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).

• Indications for exogenous insulin therapy.

• Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).

• Insulin-naive patients or prior insulin therapy at least 6 months before randomization.

• The subject is able and willing to comply with the requirements of the study protocol

Exclusion Criteria:

• Contraindication to the use of insulin aspart 30 mix.

• 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 severe hypoglycemia for 6 months before the screening.

• History of severe hyperglycemia for 6 months before the screening.

• Bariatric surgery for 12 months to screening.

• Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.

• Insulin resistance over 1.5 U/kg insulin pro day.

• Change INN of insulin for 6 months before the randomisation.

• History of treatment any experimental drugs or medical devices for 3 months before the randomisation.

• Presence of severe diabetes complications.

• Night work.

• History of administration of glucocorticoids (14 days or more) for 1 year before the screening.

• Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).

• History of vaccination for 6 months before the randomisation.

• History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.

• Pregnant and breast-feeding women.

• Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds or ALT or AST value > 3 folds as high as maximal normal value; Serum bilirubin value > 2 folds as high as maximal normal value (except Gilbert's syndrome).

• History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).

• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.

• Acute inflammation disease for 3 weeks before the screening.

• History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.

• History of stroke or TIA for 6 months before the screening.

• Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).

• The inability of the patient to assess their condition because of mental or physical disorders.

• History of drug, alcohol abuse for 3 years before the screening.

• History of oncology disorders for 5 years before the screening.

• History of transplantation, except 3 months after a corneal transplant.

• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GP40081
1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.
• NovoMix 30
1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

Locations

Country	Name	City	State
Russian Federation	Arkhangelsk Regional Clinical Hospital	Arkhangel'sk
Russian Federation	Kazan Endocrinology Dispensary	Kazan
Russian Federation	Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky	Krasnoyarsk
Russian Federation	V.A. Baranov Republic Hospital	Petrozavodsk
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg
Russian Federation	City Diagnostic Center ? 1	Saint Petersburg
Russian Federation	City Hospital ? 2	Saint Petersburg
Russian Federation	City Polyclinic ? 117	Saint Petersburg
Russian Federation	EosMed	Saint Petersburg
Russian Federation	Institute of Medical Research	Saint Petersburg
Russian Federation	Pokrovskaya Municipal Hospital	Saint Petersburg
Russian Federation	Research Center Eco-Safety	Saint Petersburg
Russian Federation	Diabetes Center	Samara
Russian Federation	Volgograd Region Clinical Hospital ?1	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
Geropharm

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	Change from baseline in titer of antibodies to human insulin	26 weeks
Secondary	Glycated hemoglobin	Change in HbA1c from baseline	26 weeks
Secondary	Adverse Events frequency and degree	Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions	26 weeks
Secondary	Fasting Plasma Glucose Level	Change in fasting plasma glucose level from baseline	26 weeks
Secondary	Seven-Point Glucose Testing	Change in seven-point glucose testing results from baseline	22 weeks
Secondary	Total Insulin Dose	Change in total insulin dose per body weight (U/kg) from baseline	22 weeks
Secondary	Body Mass Index	Change in BMI from baseline	26 weeks
Secondary	Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire	Change in treatment satisfaction from baseline. Questions 1, 4, 5, 6, 7 and 8 assesses treatment satisfaction (summed these 6 questions). Questions 2 and 3 assess the burden from hyper- and hypoglycemia. DTSQ is The Diabetes Treatment Satisfaction Questionnaire, scored from 0-36 points with higher scores indicating better satisfaction.	26 weeks
Secondary	Achievement of Glycated Hemoglobin Goals	The frequency of achievement glycated hemoglobin goals	26 weeks
Secondary	Achievement of Glycated Hemoglobin < 7%	The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)	26 weeks