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
Verified date | September 2019 |
Source | Geropharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Geropharm |
Russian Federation,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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