T2DM (Type 2 Diabetes Mellitus)NCT04682795
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
A study testing Needle-free injector and Insulin pen in people with T2DM (Type 2 Diabetes Mellitus) and Needle-free Injector, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 21 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Needle-free Injector, Time in Range
- What is being tested?
- Needle-free injector and Insulin pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 21 sitesChina
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites, 21 recruiting
- Not yet recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
Changxing, Zhejiang
Jing Li, 15306821602, tom427@163.com
- Not yet recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000
Lan Shou, 18958137771, 358897118@qq.com
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Yuezhong Ren, +8657189713764, renyuez@zju.edu.cn
Yuezhong Z Ren, MD
- Not yet recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Xianfeng Zhang, 13858023138, zxf2541@zju.edu.cn
- Not yet recruiting
The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
Jiang Hu, zjsxhyygcp@126.com
- Not yet recruiting
The First People's Hospital of Xiaoshan
Hangzhou, Zhejiang
Jun Chen, 15925676818, 64774630@qq.com
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Jianping Yao, 13567288210, gtl52@163.com
- Not yet recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang
Qiang Zhou, 15990351200, jxsdyyyqx@163.com
- Not yet recruiting
Jinhua Municipal Central Hospital Medical Group
Jinhua, Zhejiang
Huaying Huang, 13516970225, 13516970225@139.com
- Not yet recruiting
Lanxi People's Hospital
Lanxi, Zhejiang
Xiaochun Lan, 13600694315, LXYYLXC@163.com
- Not yet recruiting
Lishui People's Hospital
Lishui, Zhejiang
Riqiu Chen, 18957091378, zjlscrq321@126.com
- Not yet recruiting
Ningbo First Hospital
Ningbo, Zhejiang
Shengnan Xu, 13429253237, 304494753@qq.com
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Lingling Fang, 13958297977, cxyangy@126.com
- Not yet recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang
Weishen Gong, 13958236139, gongwk@vip.126.com
- Not yet recruiting
Quzhou People's Hospital
Quzhou, Zhejiang
Chaohui Hu, 15605709398
- Not yet recruiting
Shangyu People's Hospital of Shaoxing
Shaoxing, Zhejiang
Weiping Tu, 13858586136, 605114744@qq.com
- Not yet recruiting
The Affiliated Hospital of Shaoxing University
Shaoxing, Zhejiang
Huizhen Zhou, 13983552029, 844966981@qq.com
- Not yet recruiting
Taizhou Hospital
Taizhou, Zhejiang
Zuhua Gao, 13586151069, gaozh@enzemed.com
- Not yet recruiting
Tongxiang First Hospital
Tongxiang, Zhejiang
Fenjuan Xu, 13819057620, xufenjuan2001@163.com
- Not yet recruiting
The First People's Hospital of Wenling
Wenling, Zhejiang
Haiyang Lin, 13867617958, 13609380@qq.com
- Not yet recruiting
Zhoushan Hospital
Zhoushan, Zhejiang
Yan Jing, 17858292396, euginia1976@163.com
About this study
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.
Read the detailed 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.
- Being tested
- Needle-free injector, Insulin pen
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-free injectorDevice
Using needle-free injector as insulin carrier to treat T2DM
Insulin penDevice
Using insulin pen as insulin carrier to treat T2DM
| Study group | Role | What they receive |
|---|---|---|
| Needle-free injector group | Experimental | To evaluate the efficacy and safety of the needle-free injector in T2DM Receives: Device: Needle-free injector |
| Insulin pen group | Active comparator | To evaluate the efficacy and safety of the insulin pen in T2DM Receives: Device: Insulin pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time In Range
Time In Range (TIR, 3.9-10mmol/L)
Measured: 2 weeks
Secondary outcomes (6)
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)
Measured: 2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Occurrence of a treat to target response and without any hypoglycemic episodes
Measured: 2 weeks
EQ-5D Health Questionnaire
the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
Measured: 2 weeks
EQ-VAS Health Questionnaire
the EQ-VAS. The change from baseline after 2 weeks of treatment
Measured: 2 weeks
Short Form 36 (SF-36)
The change from baseline after 2 weeks of treatment
Measured: 2 weeks
Insulin dose
The change from baseline after 2 weeks of treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682795
- Sponsor's protocol ID
- 2020-811
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04682795
- Acronym / sponsor ID
- 2020-811
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle-free injector group | Experimental | Device: Needle-free injectorTo evaluate the efficacy and safety of the needle-free injector in T2DM |
| Insulin pen group | Active comparator | Device: Insulin penTo evaluate the efficacy and safety of the insulin pen in T2DM |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle-free injectorUsing needle-free injector as insulin carrier to treat T2DM | Device | Needle-free injector group |
| Insulin penUsing insulin pen as insulin carrier to treat T2DM | Device | Insulin pen group |
Primary outcome
Time In Range
Time frame: 2 weeks
Time In Range (TIR, 3.9-10mmol/L)
6 secondary outcomes
Time to occurrence of treat to target
Time frame: 2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Time frame: 2 weeks
EQ-5D Health Questionnaire
Time frame: 2 weeks
EQ-VAS Health Questionnaire
Time frame: 2 weeks
Short Form 36 (SF-36)
Time frame: 2 weeks
Insulin dose
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle-free injector and Insulin pen in people with T2DM (Type 2 Diabetes Mellitus) and Needle-free Injector, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuezhong Ren, MD (+8657189713764, renyuez@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time In Range (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.