Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose

NCT03243903 | Completed

• 1 other identifier: KSE01
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, QS-M needle-free injector and needle-insulin pen were used as a drug carrier to control blood glucose in type 2 diabetic patients（T2DM）.The efficacy and safety of QS-M needle-free injector and needle-insulin pen were evaluated and compared.This is a needle-insulin pen as control group, using a prospective, multicenter, randomized, open, parallel grouping study.

Conditions

Diabetes

Keywords

T2DM; QS-M needle free injector; insulin pen; effective; safety

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin (HbA1c)

  The changes in glycosylated hemoglobin (HbA1c) value between the 16th week of treatment and the start of the adjustment period (using NGSP approved detection method to detect the glycosylated hemoglobin values) .

  16weeks

Secondary Outcomes (1)

• Self-monitoring of blood glucose(SMBG)

  16 weeks

Other Outcomes (5)

• The rate of glycosylated hemoglobin

  16 weeks

• SF-36

  16 weeks

• Insulin dose

  16 weeks

Study Arms (2)

needle-free insulin injector

EXPERIMENTAL

Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.

Device: QS-M insulin-free injector

conventional insulin pen

ACTIVE COMPARATOR

Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.

Device: conventional insulin pen

Interventions

QS-M insulin-free injector DEVICE

Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.

needle-free insulin injector

conventional insulin pen DEVICE

Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.

conventional insulin pen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have been diagnosed with type 2 diabetes; (A) have been treated with insulin (premixed or basal) subcutaneous injection therapy (without limitation or combined oral hypoglycemic agents); (B) the subjects with poor blood sugar control is taking oral hypoglycemic agents or living interventions need Initiating insulin therapy (see Appendix 1 for initiating treatment regimens);
• adults aged 18-75 years, women of childbearing age need to take adequate contraceptive measures to reduce the pregnancy risk to the minimum;
• injection of insulin and / or oral hypoglycemic agents ≥ 3 months before enroll the study, the insulin dose adjustment ≤ 10% within 1 month before enrolling (adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
• have a HbAlc value (detected by NGSP approved method) between 7.5-11% ;
• BMI ≤ 32kg / m2, the body weight remained relatively stable, body weight change of no more than 10% at least 3 months before screening,
• Male subjects hemoglobin≥12g/dl (≥ 120g / L), female subjects hemoglobin ≥ 11g / dl (≥ 110g / L);
• serum creatinine \<1.5 mg / dL for male subjects, serum creatinine \<1.4 mg / dL for female subjects;
• have not participated in other clinical studies related diabetes treatment within 3 months ;
• be volunteered to participate in this clinical study and signed informed consent.

You may not qualify if:

• the persons who attend or perform this study;
• women in pregnancy or lactation;
• have frequent severe hypoglycaemia in one month; have blood glucose control adverse events like diabetic ketoacidosis or hyperosmotic diabetic coma within half a year;
• have severe cardiovascular events in the past 6 months, such as myocardial infarction, acute coronary syndrome, cerebral infarction, cardiovascular and cerebrovascular surgery;
• have used hormones or immunosuppressive agents, or have immunologic deficiency disease;
• have end-stage renal disease, and are receiving dialysis treatment;
• have of history of cancer within 5 years;
• have history of severe mental instability;
• have long-term alcohol abuse or drug abuse history;
• have Skin lesions in the insulin injection site;
• have history of anemia caused by hemoglobinopathy (such as sickle cell red blood cell anemia, thalassemia, sideroblastic anemia) or any other course;
• have critically ill, or life expectancy is less than one year;
• difficult to evaluate the effectiveness and safety of the device intervention;
• have a clear infection history within a month, such as pneumonia;
• have active liver disease (AST\> 3 times of normal upper limit or ALT\> 3 times of normal upper limit);

Sponsors & Collaborators

• Beijing QS Medical Technology Co., Ltd.: lead

Study Sites (1)

Peking University People 's Hospital

Beijing, Beijing Municipality, 10000, China

Location

Related Publications (2)

• Ji L, Gao L, Chen L, Wang Y, Ma Z, Ran X, Sun Z, Xu X, Wang G, Guo L, Shan Z. Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study). EClinicalMedicine. 2020 Jun 4;23:100368. doi: 10.1016/j.eclinm.2020.100368. eCollection 2020 Jun.

  PMID: 32529176 DERIVED

• Ji L, Chen L, Wang Y, Ma Z, Ran X, Sun Z, Xu X, Wang G, Guo L, Shan Z. Study Protocol for a Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of a Needle-Free Insulin Injector and a Conventional Insulin Pen in Controlling Blood Glucose Concentrations in Chinese Patients with Type 2 Diabetes Mellitus (The FREE Study). Adv Ther. 2019 Jun;36(6):1485-1496. doi: 10.1007/s12325-019-00951-4. Epub 2019 Apr 19.

  PMID: 31004325 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ji Li Nong

  Peking University People 's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 9, 2017
• Study Start: August 18, 2017
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)