T2DM (Type 2 Diabetes Mellitus) Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients = 18 and =75 years with type 2 diabetes; - HbA1c = 7.5 to =11.0%; - 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%); - BMI = 32kg / m2. Exclusion Criteria: - Patients with any of the following conditions will be excluded: - Pregnant or lactating women - Severe hypoglycemia within one month; diabetic ketoacidosis or hyperosmotic diabetic status within 6 months prior to informed consent - Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent - Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent - Severe mental instability, or alcohol abuse, or drug abuse - Skin lesions at the insulin injection site - Cancer within 5 years prior to informed consent - Pancreatitis of severe infectious diseases within 1 months prior to informed consent - Known hypersensitivity or allergy to the insulin - Renal impairment (CKD-EPI eGFR<60ml/min) - 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 - Participation in another trial within 2 months prior to informed consent - Patients that investigators believe may fail to complete the study |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus | Changxing | Zhejiang |
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | The 2nd Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang |
China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang |
China | The First People's Hospital of Xiaoshan | Hangzhou | Zhejiang |
China | Huzhou Central Hospital | Huzhou | Zhejiang |
China | The First Hospital of Jiaxing | Jiaxing | Zhejiang |
China | Jinhua Municipal Central Hospital Medical Group | Jinhua | Zhejiang |
China | Lanxi People's Hospital | Lanxi | Zhejiang |
China | Lishui People's Hospital | Lishui | Zhejiang |
China | Ningbo First Hospital | Ningbo | Zhejiang |
China | Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang |
China | The Affiliated People's Hospital of Ningbo University | Ningbo | Zhejiang |
China | Quzhou People's Hospital | Quzhou | Zhejiang |
China | Shangyu People's Hospital of Shaoxing | Shaoxing | Zhejiang |
China | The Affiliated Hospital of Shaoxing University | Shaoxing | Zhejiang |
China | Taizhou Hospital | Taizhou | Zhejiang |
China | Tongxiang First Hospital | Tongxiang | Zhejiang |
China | The First People's Hospital of Wenling | Wenling | Zhejiang |
China | Zhoushan Hospital | Zhoushan | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Insulin treatment compliance | 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% | 2 weeks | |
Primary | Time In Range | Time In Range (TIR, 3.9-10mmol/L) | 2 weeks | |
Secondary | Time to occurrence of treat to target | Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70% (SMBG or FCGM) | 2 weeks | |
Secondary | Occurrence of a treat to target response and without any hypoglycemic episodes | Occurrence of a treat to target response and without any hypoglycemic episodes | 2 weeks | |
Secondary | EQ-5D Health Questionnaire | the EQ-5D descriptive system The change from baseline after 2 weeks of treatment | 2 weeks | |
Secondary | EQ-VAS Health Questionnaire | the EQ-VAS. The change from baseline after 2 weeks of treatment | 2 weeks | |
Secondary | Short Form 36 (SF-36) | The change from baseline after 2 weeks of treatment | 2 weeks | |
Secondary | Insulin dose | The change from baseline after 2 weeks of treatment | 2 weeks |
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