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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04682795
Other study ID # 2020-811
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2022

Study information

Verified date December 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yuezhong Ren, MD
Phone +8657189713764
Email renyuez@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Needle-free injector
Using needle-free injector as insulin carrier to treat T2DM
Insulin pen
Using insulin pen as insulin carrier to treat T2DM

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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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