Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
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
1 other identifier
interventional
200
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 1, 2021
December 1, 2020
1.3 years
December 16, 2020
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time In Range
Time In Range (TIR, 3.9-10mmol/L)
2 weeks
Secondary Outcomes (6)
Time to occurrence of treat to target
2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
2 weeks
EQ-5D Health Questionnaire
2 weeks
EQ-VAS Health Questionnaire
2 weeks
Short Form 36 (SF-36)
2 weeks
- +1 more secondary outcomes
Other Outcomes (1)
Insulin treatment compliance
2 weeks
Study Arms (2)
Needle-free injector group
EXPERIMENTALTo evaluate the efficacy and safety of the needle-free injector in T2DM
Insulin pen group
ACTIVE COMPARATORTo evaluate the efficacy and safety of the insulin pen in T2DM
Interventions
Using needle-free injector as insulin carrier to treat T2DM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
Changxing, Zhejiang, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000, China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, 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 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, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2020
First Posted
December 24, 2020
Study Start
September 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
September 1, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share