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

Not Applicable

• Conditions: Time in Range; T2DM (Type 2 Diabetes Mellitus); Needle-free Injector

• Registration Number: NCT04682795
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Last Update Submitted: 2021-08-30
• Study Start: 2021-09-01
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time In Range	2 weeks	Time In Range (TIR, 3.9-10mmol/L)

Secondary Outcome Measures

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

Trial Locations

Locations (21)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, Changxing Campus; 🇨🇳 Changxing, Zhejiang, China

The Affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, 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 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

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