Clinical trial NCT04682795: 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
Overall status: UNKNOWN
Phase: NA
Conditions: T2DM (Type 2 Diabetes Mellitus)
Needle-free Injector
Time in Range
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time In Range
timeFrame: 2 weeks
Secondary outcomes:
measure: Time to occurrence of treat to target
timeFrame: 2 weeks
measure: Occurrence of a treat to target response and without any hypoglycemic episodes
timeFrame: 2 weeks
measure: EQ-5D Health Questionnaire
timeFrame: 2 weeks
measure: EQ-VAS Health Questionnaire
timeFrame: 2 weeks
measure: Short Form 36 (SF-36)
timeFrame: 2 weeks
measure: Insulin dose
timeFrame: 2 weeks
Other outcomes:
measure: Insulin treatment compliance
timeFrame: 2 weeks
Locations:
city: Changxing
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus
state: Zhejiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The 2nd Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: The First People's Hospital of Xiaoshan
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital Medical Group
state: Zhejiang
city: Lanxi
country: China
facility: Lanxi People's Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shangyu People's Hospital of Shaoxing
state: Zhejiang
city: Shaoxing
country: China
facility: The Affiliated Hospital of Shaoxing University
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Tongxiang
country: China
facility: Tongxiang First Hospital
state: Zhejiang
city: Wenling
country: China
facility: The First People's Hospital of Wenling
state: Zhejiang
city: Zhoushan
country: China
facility: Zhoushan Hospital
state: Zhejiang
Study officials:
References: