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Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM

Primary Purpose

T2DM (Type 2 Diabetes Mellitus), Needle-free Injector, Time in Range

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Needle-free injector
Insulin pen
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
  • The Affiliated Hospital of Hangzhou Normal University
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
  • The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
  • The First People's Hospital of Xiaoshan
  • Huzhou Central Hospital
  • The First Hospital of Jiaxing
  • Jinhua Municipal Central Hospital Medical Group
  • Lanxi People's Hospital
  • Lishui People's Hospital
  • Ningbo First Hospital
  • Ningbo Medical Center Lihuili Hospital
  • The Affiliated People's Hospital of Ningbo University
  • Quzhou People's Hospital
  • Shangyu People's Hospital of Shaoxing
  • The Affiliated Hospital of Shaoxing University
  • Taizhou Hospital
  • Tongxiang First Hospital
  • The First People's Hospital of Wenling
  • Zhoushan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Needle-free injector group

Insulin pen group

Arm Description

To evaluate the efficacy and safety of the needle-free injector in T2DM

To evaluate the efficacy and safety of the insulin pen in T2DM

Outcomes

Primary Outcome Measures

Time In Range
Time In Range (TIR, 3.9-10mmol/L)

Secondary Outcome Measures

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)
Occurrence of a treat to target response and without any hypoglycemic episodes
Occurrence of a treat to target response and without any hypoglycemic episodes
EQ-5D Health Questionnaire
the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
EQ-VAS Health Questionnaire
the EQ-VAS. The change from baseline after 2 weeks of treatment
Short Form 36 (SF-36)
The change from baseline after 2 weeks of treatment
Insulin dose
The change from baseline after 2 weeks of treatment

Full Information

First Posted
December 16, 2020
Last Updated
August 30, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04682795
Brief Title
Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2DM (Type 2 Diabetes Mellitus), Needle-free Injector, Time in Range

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Needle-free injector group
Arm Type
Experimental
Arm Description
To evaluate the efficacy and safety of the needle-free injector in T2DM
Arm Title
Insulin pen group
Arm Type
Active Comparator
Arm Description
To evaluate the efficacy and safety of the insulin pen in T2DM
Intervention Type
Device
Intervention Name(s)
Needle-free injector
Intervention Description
Using needle-free injector as insulin carrier to treat T2DM
Intervention Type
Device
Intervention Name(s)
Insulin pen
Intervention Description
Using insulin pen as insulin carrier to treat T2DM
Primary Outcome Measure Information:
Title
Time In Range
Description
Time In Range (TIR, 3.9-10mmol/L)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to occurrence of treat to target
Description
Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70% (SMBG or FCGM)
Time Frame
2 weeks
Title
Occurrence of a treat to target response and without any hypoglycemic episodes
Description
Occurrence of a treat to target response and without any hypoglycemic episodes
Time Frame
2 weeks
Title
EQ-5D Health Questionnaire
Description
the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
Time Frame
2 weeks
Title
EQ-VAS Health Questionnaire
Description
the EQ-VAS. The change from baseline after 2 weeks of treatment
Time Frame
2 weeks
Title
Short Form 36 (SF-36)
Description
The change from baseline after 2 weeks of treatment
Time Frame
2 weeks
Title
Insulin dose
Description
The change from baseline after 2 weeks of treatment
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Insulin treatment compliance
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%
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuezhong Ren, MD
Phone
+8657189713764
Email
renyuez@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
City
Changxing
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Li
Phone
15306821602
Email
tom427@163.com
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Shou
Phone
18958137771
Email
358897118@qq.com
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuezhong Ren
Phone
+8657189713764
Email
renyuez@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuezhong Z Ren, MD
Facility Name
Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianfeng Zhang
Phone
13858023138
Email
zxf2541@zju.edu.cn
Facility Name
The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Hu
Email
zjsxhyygcp@126.com
Facility Name
The First People's Hospital of Xiaoshan
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen
Phone
15925676818
Email
64774630@qq.com
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Yao
Phone
13567288210
Email
gtl52@163.com
Facility Name
The First Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Zhou
Phone
15990351200
Email
jxsdyyyqx@163.com
Facility Name
Jinhua Municipal Central Hospital Medical Group
City
Jinhua
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaying Huang
Phone
13516970225
Email
13516970225@139.com
Facility Name
Lanxi People's Hospital
City
Lanxi
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochun Lan
Phone
13600694315
Email
LXYYLXC@163.com
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riqiu Chen
Phone
18957091378
Email
zjlscrq321@126.com
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengnan Xu
Phone
13429253237
Email
304494753@qq.com
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingling Fang
Phone
13958297977
Email
cxyangy@126.com
Facility Name
The Affiliated People's Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weishen Gong
Phone
13958236139
Email
gongwk@vip.126.com
Facility Name
Quzhou People's Hospital
City
Quzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaohui Hu
Phone
15605709398
Facility Name
Shangyu People's Hospital of Shaoxing
City
Shaoxing
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiping Tu
Phone
13858586136
Email
605114744@qq.com
Facility Name
The Affiliated Hospital of Shaoxing University
City
Shaoxing
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huizhen Zhou
Phone
13983552029
Email
844966981@qq.com
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuhua Gao
Phone
13586151069
Email
gaozh@enzemed.com
Facility Name
Tongxiang First Hospital
City
Tongxiang
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fenjuan Xu
Phone
13819057620
Email
xufenjuan2001@163.com
Facility Name
The First People's Hospital of Wenling
City
Wenling
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyang Lin
Phone
13867617958
Email
13609380@qq.com
Facility Name
Zhoushan Hospital
City
Zhoushan
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Jing
Phone
17858292396
Email
euginia1976@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM

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