Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 5:44 PM
Study NCT ID:
NCT04236895
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C027235', 'term': 'gallium nitrate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The trial will be a randomized, double-blind, multicenter, single-dose, 3-way crossover, 3-treatment, euglycemic glucose clamp trial in male subjects with type 1 diabetes mellitus'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-17', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK endpoint', 'timeFrame': 'Up to 24 hours', 'description': 'AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours'}, {'measure': 'PK endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'Cins.max, maximum observed insulin concentration.'}, {'measure': 'PD endpoint', 'timeFrame': 'Up to 24 hours', 'description': 'AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours.'}, {'measure': 'PD endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'GIR max, maximum observed glucose infusion rate'}], 'secondaryOutcomes': [{'measure': 'Secondary PK endpoint', 'timeFrame': 'Up to 24 hrs', 'description': 'AUC ins.0-12h, AUC ins.12 - 24h, AUC ins.0 -inf., areas under the serum insulin concentration curve in the indicated time intervals'}, {'measure': 'Secondary PK endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'tmax.ins, time to maximum observed serum insulin concentration'}, {'measure': 'Exploratory PK endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 't½, terminal serum elimination half-life calculated as t½=ln2/λz and'}, {'measure': 'Exploratory PK endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'λz, terminal elimination rate constant'}, {'measure': 'Secondary PD endpoint', 'timeFrame': 'Up to 24 hrs', 'description': 'AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals'}, {'measure': 'Secondary PD endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp'}, {'measure': 'Secondary PD endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 't max.GIR, time to maximum glucose infusion rate'}, {'measure': 'Exploratory PD endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'Duration of action, time until blood glucose levels is consistently above 150 mg/dL'}, {'measure': 'Exploratory PD endpoint', 'timeFrame': 'Up to 30 hrs', 'description': 'Time to onset of action, time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from - 6 to - 2 minutes before trial product administration as measured by ClampArt.'}, {'measure': 'Safety endpoints', 'timeFrame': 'Up to 12 Weeks', 'description': 'As measured by treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Diabetes Type 1', 'Type 1', 'Basal', 'Insulin', 'Glargine', 'T1DM', 'Diabetes Mellitus', 'Insulin Dependent Diabetes'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '37735841', 'type': 'DERIVED', 'citation': 'Chen W, Lu J, Plum-Morschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin(R)), lispro (prandilin(R)) and glargine (basalin(R)) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'Primary objectives:\n\nTo demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.\n\nmax) of Gan \\& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes\n\nTo demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan \\& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes\n\nSecondary objectives:\n\nTo compare the pharmacokinetic and pharmacodynamic properties of Gan \\& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)\n\nTo assess the safety and tolerability of Gan \\& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).\n* Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically.\n* Age between 18 and 64 years, both inclusive.\n* Body Mass Index (BMI) between 18.5 and 29.0 kg/m\\^2, both inclusive.\n* HbA1c \\<= 9.0%.\n* Fasting negative C-peptide (\\<= 0.30 nmol/L).\n* Total insulin dose of \\< 1.2 (I)U/kg/day.\n* Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).\n* Considered generally healthy (apart from type 1 diabetes mellitus) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to IMPs or related products\n* Previous participation in this trial. Participation is defined as randomized\n* Receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) before randomization in this trial\n* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction\n* Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator\n* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator\n* Proliferative retinopathy or maculopathy (based on a recent (\\<1.5 years) ophthalmologic examination) and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator\n* Recurrent severe hypoglycemia (more than 1 severe hypoglycemic event during the past 6 months) or hypoglycemic unawareness as judged by the Investigator\n* Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator\n* Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day\n* Symptomatic hypotension or supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-140 mmHg for systolic or greater than 90 mmHg for diastolic pressure\n* Heart rate at rest outside the range of 50-90 beats per minute\n* Clinically significant abnormal standard 12-lead ECG after 5 minutes resting in supine position at screening, as judged by the Investigator\n* A positive result in the alcohol and/or urine drug screen at the screening visit\n* Not able or willing to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period\n* Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen\n* Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of occasional use of Paracetamol or NSAIDs\n* Blood donation or blood loss of more than 500 mL within the last 3 months\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation\n* Fertile male with female partner(s) without using a highly effective contraceptive method in combination with spermicide-coated condoms from the first dosing until 1 month after dosing'}, 'identificationModule': {'nctId': 'NCT04236895', 'briefTitle': 'PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gan and Lee Pharmaceuticals, USA'}, 'officialTitle': 'A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GL-GLA-CT1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus ® US', 'description': 'Insulin glargine (Lantus®, product approved and marketed in the USA (US RLD)), 100 U/mL in 3 mL pre-filled pens', 'interventionNames': ['Drug: Gan & Lee Insulin Glargine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lantus ® EU', 'description': 'Insulin glargine (Lantus®, product marketed in Germany (EU RP)), 100 U/mL in 3 ml pre-filled pens', 'interventionNames': ['Drug: Gan & Lee Insulin Glargine Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Gan & Lee Insulin Glargine', 'description': 'Insulin glargine 100 U/mL in 3 mL pre-filled pens', 'interventionNames': ['Drug: Gan & Lee Insulin Glargine Injection']}], 'interventions': [{'name': 'Gan & Lee Insulin Glargine Injection', 'type': 'DRUG', 'description': 'All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.', 'armGroupLabels': ['Gan & Lee Insulin Glargine', 'Lantus ® EU', 'Lantus ® US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Profil Mainz GmbH & Co. KG', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Jia Lu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gan & Lee Pharmaceuticals, USA'}, {'name': 'Leona Plum - Mörschel, MD, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Mainz GmbH & Co KG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gan and Lee Pharmaceuticals, USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}