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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682795
• Other study ID #: 2020-811
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuezhong Ren, MD
• Phone: +8657189713764
• Email: renyuez[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Needle-free injector
Using needle-free injector as insulin carrier to treat T2DM
• Insulin pen
Using insulin pen as insulin carrier to treat T2DM

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin treatment compliance	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
Primary	Time In Range	Time In Range (TIR, 3.9-10mmol/L)	2 weeks
Secondary	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)	2 weeks
Secondary	Occurrence of a treat to target response and without any hypoglycemic episodes	Occurrence of a treat to target response and without any hypoglycemic episodes	2 weeks
Secondary	EQ-5D Health Questionnaire	the EQ-5D descriptive system The change from baseline after 2 weeks of treatment	2 weeks
Secondary	EQ-VAS Health Questionnaire	the EQ-VAS. The change from baseline after 2 weeks of treatment	2 weeks
Secondary	Short Form 36 (SF-36)	The change from baseline after 2 weeks of treatment	2 weeks
Secondary	Insulin dose	The change from baseline after 2 weeks of treatment	2 weeks