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

January 31, 2018 updated by: Xijing Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital, Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: QS-M Needle Free Injector group
To observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group.
Device: QS-M Needle Free Injector
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
ACTIVE_COMPARATOR: Glargine pen group
To observe the amount of insulin used by the Glargine pen group under good blood glucose control.
Device: Glargine pen
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting blood glucose between baseline to week 4
Time Frame: baseline and week 4
fasting blood glucose are measured at baseline and week 4
baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Qiuhe Ph.D Ji, M.D., Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 27, 2017

Primary Completion (ANTICIPATED)

February 20, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20172077-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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