Type 2 Diabetes MellitusNCT03420040
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use
A study testing QS-M Needle Free Injector and Glargine pen in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- QS-M Needle Free Injector and Glargine pen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical university
Xi'an, Shaanxi, 710032
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- QS-M Needle Free Injector, Glargine pen
- Keywords
- Glargine Insulin, QS-M Needle Free Injector
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Glargine penDevice
The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Glargine pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose between baseline to week 4
fasting blood glucose are measured at baseline and week 4
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start27 Nov 2017
- Primary completion20 Feb 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiuhe Ph.D Ji, M.D., Principal investigator, Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420040
- Sponsor's protocol ID
- KY20172077-1
- Status last verified
- Dec 2017
- First submitted
- 9 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31359813
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03420040
- Acronym / sponsor ID
- KY20172077-1
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glargine Insulin, QS-M Needle Free Injector
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 20 Feb 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QS-M Needle Free Injector group | Experimental | Device: QS-M Needle Free InjectorTo observe the use of insulin in glycemia under good blood glucose control in the QS-M Needle Free Injector group. |
| Glargine pen group | Active comparator | Device: Glargine penTo observe the amount of insulin used by the Glargine pen group under good blood glucose control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QS-M Needle Free InjectorThe subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection | Device | QS-M Needle Free Injector group |
| Glargine penThe subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection | Device | Glargine pen group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 31359813Xing 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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiuhe Ph.D Ji, M.D. principal investigator
Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QS-M Needle Free Injector and Glargine pen in people with Type 2 Diabetes Mellitus, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose between baseline to week 4 (time frame: baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.