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

August 30, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Changxing, Zhejiang, China
        • Not yet recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
        • Contact:
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The Affiliated Hospital of Hangzhou Normal University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • The First People's Hospital of Xiaoshan
        • Contact:
      • Huzhou, Zhejiang, China
        • Not yet recruiting
        • Huzhou Central Hospital
        • Contact:
      • Jiaxing, Zhejiang, China
        • Not yet recruiting
        • The First Hospital of Jiaxing
        • Contact:
      • Jinhua, Zhejiang, China
        • Not yet recruiting
        • Jinhua Municipal Central Hospital Medical Group
        • Contact:
      • Lanxi, Zhejiang, China
        • Not yet recruiting
        • Lanxi People's Hospital
        • Contact:
      • Lishui, Zhejiang, China
        • Not yet recruiting
        • Lishui People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • Ningbo First Hospital
        • Contact:
      • Ningbo, Zhejiang, China
        • Not yet recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
      • Quzhou, Zhejiang, China
        • Not yet recruiting
        • Quzhou People's Hospital
        • Contact:
          • Chaohui Hu
          • Phone Number: 15605709398
      • Shaoxing, Zhejiang, China
        • Not yet recruiting
        • The Affiliated Hospital of Shaoxing University
        • Contact:
      • Shaoxing, Zhejiang, China
        • Not yet recruiting
        • Shangyu People's Hospital of Shaoxing
        • Contact:
      • Taizhou, Zhejiang, China
        • Not yet recruiting
        • Taizhou Hospital
        • Contact:
      • Tongxiang, Zhejiang, China
        • Not yet recruiting
        • Tongxiang First Hospital
        • Contact:
      • Wenling, Zhejiang, China
        • Not yet recruiting
        • The First People's Hospital of Wenling
        • Contact:
      • Zhoushan, Zhejiang, China
        • Not yet recruiting
        • Zhoushan hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Needle-free injector group
To evaluate the efficacy and safety of the needle-free injector in T2DM
Device: Needle-free injector
Using needle-free injector as insulin carrier to treat T2DM
ACTIVE_COMPARATOR: Insulin pen group
To evaluate the efficacy and safety of the insulin pen in T2DM
Device: Insulin pen
Using insulin pen as insulin carrier to treat T2DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time In Range
Time Frame: 2 weeks
Time In Range (TIR, 3.9-10mmol/L)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to occurrence of treat to target
Time Frame: 2 weeks
Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70% (SMBG or FCGM)
2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Time Frame: 2 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
2 weeks
EQ-5D Health Questionnaire
Time Frame: 2 weeks
the EQ-5D descriptive system The change from baseline after 2 weeks of treatment
2 weeks
EQ-VAS Health Questionnaire
Time Frame: 2 weeks
the EQ-VAS. The change from baseline after 2 weeks of treatment
2 weeks
Short Form 36 (SF-36)
Time Frame: 2 weeks
The change from baseline after 2 weeks of treatment
2 weeks
Insulin dose
Time Frame: 2 weeks
The change from baseline after 2 weeks of treatment
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin treatment compliance
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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