Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04682795
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin treatment compliance', 'timeFrame': '2 weeks', 'description': 'Recording whether the subjects obey the program to inject insulin at the specified time point in the 1st, 2nd, 3rd visit. Compliance will be calculated according to the formula: Compliance(%) = （Number of injections actually administered /Number of injections which should have been administered in the same period）\\*100%'}], 'primaryOutcomes': [{'measure': 'Time In Range', 'timeFrame': '2 weeks', 'description': 'Time In Range (TIR, 3.9-10mmol/L)'}], 'secondaryOutcomes': [{'measure': 'Time to occurrence of treat to target', 'timeFrame': '2 weeks', 'description': 'Fasting glucose on treatment \\<7mmol/L and non-fasting glucose \\<10mmol/L, or TIR \\>70% (SMBG or FCGM)'}, {'measure': 'Occurrence of a treat to target response and without any hypoglycemic episodes', 'timeFrame': '2 weeks', 'description': 'Occurrence of a treat to target response and without any hypoglycemic episodes'}, {'measure': 'EQ-5D Health Questionnaire', 'timeFrame': '2 weeks', 'description': 'the EQ-5D descriptive system The change from baseline after 2 weeks of treatment'}, {'measure': 'EQ-VAS Health Questionnaire', 'timeFrame': '2 weeks', 'description': 'the EQ-VAS. The change from baseline after 2 weeks of treatment'}, {'measure': 'Short Form 36 (SF-36)', 'timeFrame': '2 weeks', 'description': 'The change from baseline after 2 weeks of treatment'}, {'measure': 'Insulin dose', 'timeFrame': '2 weeks', 'description': 'The change from baseline after 2 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T2DM (Type 2 Diabetes Mellitus)', 'Needle-free Injector', 'Time in Range']}, 'descriptionModule': {'briefSummary': 'In this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patients with type 2 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in Time in Range (TIR), a newly recommended measurement of blood glucose fluctuations.', 'detailedDescription': 'The objective of the current study is to investigate the efficacy, safety and tolerability of needle-free injector compared to conventional insulin pen given for 2 weeks as the insulin carrier in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in TIR (after 2 weeks of treatment) in all patients with baseline and at least one post baseline measurement. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 200 patients will be enrolled in the study. Patients who qualify will be randomized to needle-free injector group or conventional insulin pen group. Duration of treatment includes 1-week screening period, 2-week treatment observation period and 2-week follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 and ≤75 years with type 2 diabetes;\n* HbA1c ≥ 7.5 to ≤11.0%;\n* Receipt of premixed insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study, and insulin dose adjustments ≤ 10% within 4 weeks before enrollment (dose adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);\n* BMI ≤ 32kg / m2.\n\nExclusion Criteria:\n\n* Patients with any of the following conditions will be excluded:\n* Pregnant or lactating women\n* Severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent\n* Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent\n* Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent\n* Severe mental instability, or alcohol abuse, or drug abuse\n* Skin lesions at the insulin injection site\n* Cancer within 5 years prior to informed consent\n* Pancreatitis of severe infectious diseases within 1 months prior to informed consent\n* Known hypersensitivity or allergy to the insulin\n* Renal impairment (CKD-EPI eGFR\\<60ml/min)\n* Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined\n* Participation in another trial within 2 months prior to informed consent\n* Patients that investigators believe may fail to complete the study'}, 'identificationModule': {'nctId': 'NCT04682795', 'briefTitle': 'Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Prospective, Multi-center, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Needle-free Injector Versus Insulin Pen in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2020-811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Needle-free injector group', 'description': 'To evaluate the efficacy and safety of the needle-free injector in T2DM', 'interventionNames': ['Device: Needle-free injector']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin pen group', 'description': 'To evaluate the efficacy and safety of the insulin pen in T2DM', 'interventionNames': ['Device: Insulin pen']}], 'interventions': [{'name': 'Needle-free injector', 'type': 'DEVICE', 'description': 'Using needle-free injector as insulin carrier to treat T2DM', 'armGroupLabels': ['Needle-free injector group']}, {'name': 'Insulin pen', 'type': 'DEVICE', 'description': 'Using insulin pen as insulin carrier to treat T2DM', 'armGroupLabels': ['Insulin pen group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Li', 'role': 'CONTACT', 'email': 'tom427@163.com', 'phone': '15306821602'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus', 'geoPoint': {'lat': 30.96839, 'lon': 119.72978}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lan Shou', 'role': 'CONTACT', 'email': '358897118@qq.com', 'phone': '18958137771'}], 'facility': 'The Affiliated Hospital of Hangzhou Normal University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuezhong Ren', 'role': 'CONTACT', 'email': 'renyuez@zju.edu.cn', 'phone': '+8657189713764'}, {'name': 'Yuezhong Z Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianfeng Zhang', 'role': 'CONTACT', 'email': 'zxf2541@zju.edu.cn', 'phone': '13858023138'}], 'facility': "Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Hu', 'role': 'CONTACT', 'email': 'zjsxhyygcp@126.com'}], 'facility': 'The 2nd Affiliated Hospital of Zhejiang Chinese Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Chen', 'role': 'CONTACT', 'email': '64774630@qq.com', 'phone': '15925676818'}], 'facility': "The First People's Hospital of Xiaoshan", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Huzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Yao', 'role': 'CONTACT', 'email': 'gtl52@163.com', 'phone': '13567288210'}], 'facility': 'Huzhou Central Hospital', 'geoPoint': {'lat': 30.8703, 'lon': 120.0933}}, {'city': 'Jiaxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Zhou', 'role': 'CONTACT', 'email': 'jxsdyyyqx@163.com', 'phone': '15990351200'}], 'facility': 'The First Hospital of Jiaxing', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaying Huang', 'role': 'CONTACT', 'email': '13516970225@139.com', 'phone': '13516970225'}], 'facility': 'Jinhua Municipal Central Hospital Medical Group', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Lanxi', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaochun Lan', 'role': 'CONTACT', 'email': 'LXYYLXC@163.com', 'phone': '13600694315'}], 'facility': "Lanxi People's Hospital", 'geoPoint': {'lat': 29.21588, 'lon': 119.47156}}, {'city': 'Lishui', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Riqiu Chen', 'role': 'CONTACT', 'email': 'zjlscrq321@126.com', 'phone': '18957091378'}], 'facility': "Lishui People's Hospital", 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengnan Xu', 'role': 'CONTACT', 'email': '304494753@qq.com', 'phone': '13429253237'}], 'facility': 'Ningbo First Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lingling Fang', 'role': 'CONTACT', 'email': 'cxyangy@126.com', 'phone': '13958297977'}], 'facility': 'Ningbo Medical Center Lihuili Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weishen Gong', 'role': 'CONTACT', 'email': 'gongwk@vip.126.com', 'phone': '13958236139'}], 'facility': "The Affiliated People's Hospital of Ningbo University", 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Quzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chaohui Hu', 'role': 'CONTACT', 'phone': '15605709398'}], 'facility': "Quzhou People's Hospital", 'geoPoint': {'lat': 28.95944, 'lon': 118.86861}}, {'city': 'Shaoxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiping Tu', 'role': 'CONTACT', 'email': '605114744@qq.com', 'phone': '13858586136'}], 'facility': "Shangyu People's Hospital of Shaoxing", 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'city': 'Shaoxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huizhen Zhou', 'role': 'CONTACT', 'email': '844966981@qq.com', 'phone': '13983552029'}], 'facility': 'The Affiliated Hospital of Shaoxing University', 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zuhua Gao', 'role': 'CONTACT', 'email': 'gaozh@enzemed.com', 'phone': '13586151069'}], 'facility': 'Taizhou Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'city': 'Tongxiang', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fenjuan Xu', 'role': 'CONTACT', 'email': 'xufenjuan2001@163.com', 'phone': '13819057620'}], 'facility': 'Tongxiang First Hospital', 'geoPoint': {'lat': 30.63287, 'lon': 120.56081}}, {'city': 'Wenling', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiyang Lin', 'role': 'CONTACT', 'email': '13609380@qq.com', 'phone': '13867617958'}], 'facility': "The First People's Hospital of Wenling", 'geoPoint': {'lat': 28.37524, 'lon': 121.38416}}, {'city': 'Zhoushan', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Jing', 'role': 'CONTACT', 'email': 'euginia1976@163.com', 'phone': '17858292396'}], 'facility': 'Zhoushan Hospital', 'geoPoint': {'lat': 29.98869, 'lon': 122.20488}}], 'centralContacts': [{'name': 'Yuezhong Ren, MD', 'role': 'CONTACT', 'email': 'renyuez@zju.edu.cn', 'phone': '+8657189713764'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}