Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06199505
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline to Week 16', 'description': 'Change in body weight from baseline to week 16 is presented.'}], 'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Baseline to week 16', 'description': 'Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline to Week 16', 'description': 'Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment'}, {'measure': 'The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16', 'timeFrame': 'Week 16', 'description': 'The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented.'}, {'measure': 'Incidence and Rate of hypoglycemia Events', 'timeFrame': 'Baseline to Week 16', 'description': 'Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (\\>=) 3.0 and less than (\\<) 3.9 mmol/L (\\>= 54 and \\< 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery.'}, {'measure': 'Incidence and Rate of Treatment-emergent AE/SAEs', 'timeFrame': 'Baseline to Week 16', 'description': 'A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.'}, {'measure': 'Change from baseline in ADA and Nab', 'timeFrame': 'Baseline to Week 16', 'description': 'Samples from the GZR101 arm of the study were analysed for anti-drug antibodies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.\n* BMI = 18.5-35 kg/m2 (inclusive) at screening.\n* Diagnosed with type 2 diabetes mellitus for ≥ 6 months.\n* 7.0% ≤ HbA1c ≤ 11.0% at screening.\n\nExclusion Criteria:\n\n* Women in pregnancy or lactation.\n* Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.\n* Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.\n* Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.\n* Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.\n* Known or suspected hypersensitivity to trial product(s).\n* Participation in a clinical study of another study drug within 1 month prior to randomization.'}, 'identificationModule': {'nctId': 'NCT06199505', 'briefTitle': 'A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gan and Lee Pharmaceuticals, USA'}, 'officialTitle': 'A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin', 'orgStudyIdInfo': {'id': 'GL-GZR-CH2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GZR101', 'description': 'GZR101 injection s.c., once daily, treat-to-target dose', 'interventionNames': ['Drug: GZR101']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin degludec/insulin aspart,', 'description': 'insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose', 'interventionNames': ['Drug: insulin degledec/insulin aspart']}], 'interventions': [{'name': 'GZR101', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['GZR101']}, {'name': 'insulin degledec/insulin aspart', 'type': 'DRUG', 'description': 'Once daily or twice daily', 'armGroupLabels': ['insulin degludec/insulin aspart,']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Gan & Lee Pharmaceuticals Co., Ltd', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Chunyue Hao, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gan & Lee Pharmaceuticals.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gan and Lee Pharmaceuticals, USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}