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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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