Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT04226105
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '26 weeks', 'description': 'Change from baseline in titer of antibodies to human insulin'}], 'secondaryOutcomes': [{'measure': 'Glycated hemoglobin', 'timeFrame': '26 weeks', 'description': 'Change in HbA1c from baseline'}, {'measure': 'Adverse Events frequency and degree', 'timeFrame': '26 weeks', 'description': 'Hypoglycemic episodes (glucose level \\< 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions'}, {'measure': 'Fasting Plasma Glucose Level', 'timeFrame': '26 weeks', 'description': 'Change in fasting plasma glucose level from baseline'}, {'measure': 'Seven-Point Glucose Testing', 'timeFrame': '22 weeks', 'description': 'Change in seven-point glucose testing results from baseline'}, {'measure': 'Total Insulin Dose', 'timeFrame': '22 weeks', 'description': 'Change in total insulin dose per body weight (U/kg) from baseline'}, {'measure': 'Body Mass Index', 'timeFrame': '26 weeks', 'description': 'Change in BMI from baseline'}, {'measure': 'Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': '26 weeks', 'description': '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.'}, {'measure': 'Achievement of Glycated Hemoglobin Goals', 'timeFrame': '26 weeks', 'description': 'The frequency of achievement glycated hemoglobin goals'}, {'measure': 'Achievement of Glycated Hemoglobin < 7%', 'timeFrame': '26 weeks', 'description': 'The frequency of achievement glycated hemoglobin \\< 7% ( 7% inclusive)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written consent\n* Diabetes mellitus type 2 for at least 6 months before the screening (WHO criteria 1999-2013).\n* Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).\n* Indications for exogenous insulin therapy.\n* Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).\n* Insulin-naive patients or prior insulin therapy at least 6 months before randomization.\n* The subject is able and willing to comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Contraindication to the use of insulin aspart 30 mix.\n* 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.\n* History of severe hypoglycemia for 6 months before the screening.\n* History of severe hyperglycemia for 6 months before the screening.\n* Bariatric surgery for 12 months to screening.\n* Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.\n* Insulin resistance over 1.5 U/kg insulin pro day.\n* Change INN of insulin for 6 months before the randomisation.\n* History of treatment any experimental drugs or medical devices for 3 months before the randomisation.\n* Presence of severe diabetes complications.\n* Night work.\n* History of administration of glucocorticoids (14 days or more) for 1 year before the screening.\n* Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).\n* History of vaccination for 6 months before the randomisation.\n* History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.\n* Pregnant and breast-feeding women.\n* 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).\n* History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).\n* Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.\n* Acute inflammation disease for 3 weeks before the screening.\n* History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.\n* History of stroke or TIA for 6 months before the screening.\n* Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).\n* The inability of the patient to assess their condition because of mental or physical disorders.\n* History of drug, alcohol abuse for 3 years before the screening.\n* History of oncology disorders for 5 years before the screening.\n* History of transplantation, except 3 months after a corneal transplant.\n* History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study"}, 'identificationModule': {'nctId': 'NCT04226105', 'briefTitle': 'Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geropharm'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GP40081-P4-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP40081', 'description': 'Subcutaneous (SC), up to Week 26', 'interventionNames': ['Drug: GP40081']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NovoMix® 30 FlexPen®', 'description': 'Subcutaneous (SC), up to Week 26', 'interventionNames': ['Drug: NovoMix 30']}], 'interventions': [{'name': 'GP40081', 'type': 'DRUG', 'otherNames': ['Insulin aspart 30 mix'], 'description': '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.', 'armGroupLabels': ['GP40081']}, {'name': 'NovoMix 30', 'type': 'DRUG', 'otherNames': ['Insulin aspart 30 mix'], 'description': '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.', 'armGroupLabels': ['NovoMix® 30 FlexPen®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Hospital', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '420073', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Kazan Endocrinology Dispensary', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '660022', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '185000', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'V.A. Baranov Republic Hospital', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Diagnostic Center № 1', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Hospital № 2', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194358', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Polyclinic № 117', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195197', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'EosMed', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196084', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Institute of Medical Research', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196143', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Center Eco-Safety', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Almazov National Medical Research Centre', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '199106', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pokrovskaya Municipal Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443067', 'city': 'Samara', 'country': 'Russia', 'facility': 'Diabetes Center', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '400081', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd Region Clinical Hospital №1', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geropharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}