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A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QS-M Needle Free Injector
Glargine pen
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Glargine Insulin, QS-M Needle Free Injector

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy;
  2. the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;
  3. 18 Kg/m2 = BMI = 30Kg/m2;
  4. received daily injections of insulin glargine and also take one to three kinds of oral medicine (not including secretagogues) patients, daily insulin glargine total dose more than 12IU but <50IU, the use of insulin glargine than in January;
  5. the blood glucose in the fasting vein was in 5.0-9.0mmol/L;
  6. the letter of informed consent has been read and signed.

Exclusion Criteria:

  1. there is conflict of interest with this research.
  2. blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma.
  3. serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;
  4. severe cardiovascular events occurred in the last 6 months.
  5. the application of hormone or immunosuppressant, or low immunity defect;
  6. the use of non steroidal anti-inflammatory drugs;
  7. the use of sulfonylureas and insulin secreting agents;
  8. a person with a history of cancer;
  9. a history of unstable or rapid progressive renal disease;
  10. an unstable history of major mental illness;
  11. the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia);
  12. women who are pregnant or are breastfeeding;
  13. in the near future there is a clear infection, such as urinary tract infection and pneumonia;
  14. recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc.
  15. skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria;
  16. the history of acute pancreatitis or pancreatectomy;
  17. the researchers believe that it may lead to any situation in which the subject is unable to complete the study or may cause significant risk to the subject.
  18. the results of the laboratory examination are as follows: A. obvious abnormal liver function or in the active phase of the disease (AST> 3 times the upper limit of normal ALT> or 3 times the upper limit of normal); The creatinine clearance rate of B. was <60ml/min; C. anaemia caused by any cause of the disease; The results of pregnancy test in women of childbearing age of D. were positive.

Sites / Locations

  • Xijing Hospital, Fourth Military Medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QS-M Needle Free Injector group

Glargine pen group

Arm Description

To observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group.

To observe the amount of insulin used by the Glargine pen group under good blood glucose control.

Outcomes

Primary Outcome Measures

Change in fasting blood glucose between baseline to week 4
fasting blood glucose are measured at baseline and week 4

Secondary Outcome Measures

Full Information

First Posted
January 9, 2018
Last Updated
January 31, 2018
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03420040
Brief Title
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Official Title
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
February 20, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out. The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Glargine Insulin, QS-M Needle Free Injector

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QS-M Needle Free Injector group
Arm Type
Experimental
Arm Description
To observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group.
Arm Title
Glargine pen group
Arm Type
Active Comparator
Arm Description
To observe the amount of insulin used by the Glargine pen group under good blood glucose control.
Intervention Type
Device
Intervention Name(s)
QS-M Needle Free Injector
Intervention Description
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
Intervention Type
Device
Intervention Name(s)
Glargine pen
Intervention Description
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
Primary Outcome Measure Information:
Title
Change in fasting blood glucose between baseline to week 4
Description
fasting blood glucose are measured at baseline and week 4
Time Frame
baseline and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy; the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year; 18 Kg/m2 = BMI = 30Kg/m2; received daily injections of insulin glargine and also take one to three kinds of oral medicine (not including secretagogues) patients, daily insulin glargine total dose more than 12IU but <50IU, the use of insulin glargine than in January; the blood glucose in the fasting vein was in 5.0-9.0mmol/L; the letter of informed consent has been read and signed. Exclusion Criteria: there is conflict of interest with this research. blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma. serious diabetic complications such as diabetic foot, diabetic nephropathy and so on; severe cardiovascular events occurred in the last 6 months. the application of hormone or immunosuppressant, or low immunity defect; the use of non steroidal anti-inflammatory drugs; the use of sulfonylureas and insulin secreting agents; a person with a history of cancer; a history of unstable or rapid progressive renal disease; an unstable history of major mental illness; the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia); women who are pregnant or are breastfeeding; in the near future there is a clear infection, such as urinary tract infection and pneumonia; recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc. skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria; the history of acute pancreatitis or pancreatectomy; the researchers believe that it may lead to any situation in which the subject is unable to complete the study or may cause significant risk to the subject. the results of the laboratory examination are as follows: A. obvious abnormal liver function or in the active phase of the disease (AST> 3 times the upper limit of normal ALT> or 3 times the upper limit of normal); The creatinine clearance rate of B. was <60ml/min; C. anaemia caused by any cause of the disease; The results of pregnancy test in women of childbearing age of D. were positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiuhe Ph.D Ji, M.D.
Organizational Affiliation
Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31359813
Citation
Xing Y, Xie X, Xu J, Liu J, He Q, Yang W, Zhang N, Li X, Wang L, Fu J, Zhou J, Gao B, Ming J, Liu X, Lai J, Liu T, Shi M, Ji Q. Efficacy and safety of a needle-free injector in Chinese patients with type 2 diabetes mellitus treated with basal insulin: a multicentre, prospective, randomised, crossover study. Expert Opin Drug Deliv. 2019 Sep;16(9):995-1002. doi: 10.1080/17425247.2019.1649251. Epub 2019 Aug 5.
Results Reference
derived

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A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

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