Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients
- Conditions
- Diabetes MellitusDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04226105
- Lead Sponsor
- Geropharm
- Brief 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 264
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NovoMix® 30 FlexPen® NovoMix 30 Subcutaneous (SC), up to Week 26 GP40081 GP40081 Subcutaneous (SC), 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 Fasting Plasma Glucose Level 26 weeks Change in fasting plasma glucose level from baseline
Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire 26 weeks 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.
Total Insulin Dose 22 weeks Change in total insulin dose per body weight (U/kg) from baseline
Achievement of Glycated Hemoglobin < 7% 26 weeks The frequency of achievement glycated hemoglobin \< 7% ( 7% inclusive)
Seven-Point Glucose Testing 22 weeks Change in seven-point glucose testing results from baseline
Glycated hemoglobin 26 weeks Change in HbA1c from baseline
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
Body Mass Index 26 weeks Change in BMI from baseline
Achievement of Glycated Hemoglobin Goals 26 weeks The frequency of achievement glycated hemoglobin goals
Trial Locations
- Locations (14)
Almazov National Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
City Polyclinic № 117
🇷🇺Saint Petersburg, Russian Federation
Volgograd Region Clinical Hospital №1
🇷🇺Volgograd, Russian Federation
City Diagnostic Center № 1
🇷🇺Saint Petersburg, Russian Federation
Pokrovskaya Municipal Hospital
🇷🇺Saint Petersburg, Russian Federation
V.A. Baranov Republic Hospital
🇷🇺Petrozavodsk, Russian Federation
Research Center Eco-Safety
🇷🇺Saint Petersburg, Russian Federation
Diabetes Center
🇷🇺Samara, 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
EosMed
🇷🇺Saint Petersburg, Russian Federation
City Hospital № 2
🇷🇺Saint Petersburg, Russian Federation
Institute of Medical Research
🇷🇺Saint Petersburg, Russian Federation