NCT03420040

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

January 9, 2018

Last Update Submit

January 31, 2018

Conditions

Type 2 Diabetes Mellitus

Keywords

Glargine InsulinQS-M Needle Free Injector

Outcome Measures

Primary Outcomes (1)

  • Change in fasting blood glucose between baseline to week 4

    fasting blood glucose are measured at baseline and week 4

    baseline and week 4

Study Arms (2)

QS-M Needle Free Injector group

EXPERIMENTAL

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

Glargine pen group

ACTIVE COMPARATOR

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

Device: Glargine pen

Interventions

QS-M Needle Free InjectorDEVICE

The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection

QS-M Needle Free Injector group
Glargine penDEVICE

The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection

Glargine pen group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical university

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • 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.

    PMID: 31359813DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Qiuhe Ph.D Ji, M.D.

    Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

February 5, 2018

Study Start

November 27, 2017

Primary Completion

February 20, 2018

Study Completion

April 1, 2018

Last Updated

February 5, 2018

Record last verified: 2017-12

Locations

CN(1)