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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: NovoRapid® Penfill®; Drug: GP40071

• Registration Number: NCT04079413
• Lead Sponsor: Geropharm

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-03
• Status Verified: 2019-09
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Primary Completion: 2020-01-21
• Study Completion: 2020-01-21
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NovoRapid® Penfill®	NovoRapid® Penfill®	Subcutaneous (SC), before meals intake, up to Week 26
GP40071	GP40071	Subcutaneous (SC), before meals intake, up to Week 26

Primary Outcome Measures

Name	Time	Method
Immunogenicity	26 weeks	Change from baseline in titer of antibodies to human insulin

Secondary Outcome Measures

Name	Time	Method
Adverse Events frequency and degree	26 weeks	Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions
Achievement of Glycated Hemoglobin Goals	26 weeks	The frequency of achievement glycated hemoglobin goals
Achievement of Glycated Hemoglobin < 7%	26 weeks	The frequency of achievement glycated hemoglobin \< 7% ( 7% inclusive)
Glycated hemoglobin	26 weeks	Change in HbA1c from baseline
Treatment Satisfaction	26 weeks	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.
Body Mass Index	26 weeks	Change in BMI from baseline
Fasting Plasma Glucose Level	26 weeks	Change in fasting plasma glucose level from baseline
Seven-Point Glucose Testing	26 weeks	Change in seven-point glucose testing results from baseline
Total Insulin Dose	26 weeks	Change in total insulin dose per body weight (U/kg) from baseline

Trial Locations

Locations (14)

Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky; 🇷🇺 Krasnoyarsk, Russian Federation

Institute of Medical Research; 🇷🇺 Saint Petersburg, Russian Federation

Clinical City Hospital № 9; 🇷🇺 Saratov, Russian Federation

Endocrinology Research Centre (Moscow); 🇷🇺 Moscow, Russian Federation

Diabetes Center; 🇷🇺 Samara, Russian Federation

Arkhangelsk Regional Clinical Hospital; 🇷🇺 Arkhangel'sk, Russian Federation

Polyclinic Сomplex; 🇷🇺 Saint Petersburg, 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

Kazan Endocrinology Dispensary; 🇷🇺 Kazan, Russian Federation

City Polyclinic № 117; 🇷🇺 Saint Petersburg, Russian Federation

Pokrovskaya Municipal Hospital; 🇷🇺 Saint Petersburg, Russian Federation

EosMed; 🇷🇺 Saint Petersburg, Russian Federation