Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079413
• Other study ID #: GP40071-P4-31
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2019
• Est. completion date: January 21, 2020

Study information

• Verified date: September 2019
• 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 T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: January 21, 2020
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed written consent

• Diabetes mellitus type 1 for at least 12 months prior to screening

• History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days

• Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive)

• Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive)

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

Exclusion Criteria:

• Contraindication to the use of insulin aspart

• Insulin resistance over 1.5 U/kg insulin pro day

• Change INN of insulin for 6 months prior to randomisation

• History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins)

• History of treatment any experimental drugs or medical devices for 3 months prior to randomisation

• History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump

• Presence of severe diabetes complications

• History of severe hypoglycemia for 6 months prior to screening

• History of 15 or more episodes mild hypoglycemia for 1 month prior to screening

• History or presence of uncontrolled diabetes mellitus for 6 months prior to screening

• History of administration of glucocorticoids (14 days or more) for 1 year prior to screening

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

• History of vaccination for 6 months prior to randomisation

• History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency

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

• History of stroke or TIA for 6 months prior to 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

• Pregnant and breast-feeding women

• Acute inflammation disease for 3 weeks prior to screening

• Deviation of the laboratory results conducted during the screening:

Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value

• History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)

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

• Incomplete recovery after surgery procedure

• History of drug, alcohol abuse for 3 years prior to screening

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

• History of oncological disease during 5 years prior to screening

• History of transplantation, except 3 months after 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

• Inability follow to protocol

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• GP40071
GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
• NovoRapid® Penfill®
NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) 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	Endocrinology Research Centre (Moscow)	Moscow
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg
Russian Federation	City Diagnostic Center ? 1	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	Polyclinic ?omplex	Saint Petersburg
Russian Federation	Diabetes Center	Samara
Russian Federation	Clinical City Hospital ? 9	Saratov

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	26 weeks
Secondary	Total Insulin Dose	Change in total insulin dose per body weight (U/kg) from baseline	26 weeks
Secondary	Body Mass Index	Change in BMI from baseline	26 weeks
Secondary	Treatment Satisfaction	Change in treatment satisfaction from baseline. The total score DTSQ (The Diabetes Treatment Satisfaction Questionnaire) (range 0-36). 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.	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