DiabetesNCT03243903
Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose
A study testing QS-M insulin-free injector and conventional insulin pen in people with Diabetes, run by Beijing QS Medical Technology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- QS-M insulin-free injector and conventional insulin pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2017to 8 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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);
- have history of acute pancreatitis within a month;
- have history of insulin allergy;
- have been expected to have poor compliance and can not be treated according to the research protocol;
- other cases that investigators believe that the subject may fail to complete the study or may have a significant impact.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People 's Hospital
Beijing, Beijing Municipality, 10000
About this study
Official title: The Safety and Efficacy of QS-M Needle -Free Injector Versus Needle-insulin Pen as a Drug Carrier for Controlling the Blood Glucose in T2DM：a Randomized, Parallel Controlled, Open-label, Multicenter Trial
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.
Read the detailed description
The research purpose is to evaluate the efficacy and safety of QS-M needle-free injector as a drug carrier in the control of blood glucose in patients with type 2 diabetes mellitus by non-inferiority study，using needle-insulin pen as the comparison. This is a prospective, multicenter, randomized, open and parallel grouping study. QS-M needle-free injector produced by Beijing QS medical technology co., Ltd.is used as the insulin carrier in the experimental group. While needle-insulin pen is used as the insulin carrier in the control group. In this study, the investigators investigated whether the changes of glycosylated hemoglobin (HbA1c) at the 16th week in the experimental group respected to the baseline is non-inferiority compared with that in control group. A total of 427 patients with T2DM were enrolled in a prospective, multicenter,randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks' treatment with basal insulin or premixed insulin administered either by a needle-free insulin injector (NFII)or insulin treatment via a conventional insulin pen (CIP)
Patients in both groups entered a 2-week screening period after providing their written informed consent. A run-in period from week 1 to the end of week 4 was implemented to allow treatment adjustment. Assessment visits occurred at screening (week -2), baseline, and week 1, 2, 4, 6, 8, 12 and 16.After the 4-week run-in phase, the patients entered a 12-week treatment observation period. All patients were unable to change the type of insulin and the number of injections during the study period. In this study, the treatment regimen was adjusted according to the results of the determination of prescription blood glucose. According to clinical experience, the adjustment of blood glucose fluctuations in the possibility of a larger, so the study of the adjustment phase follow-up frequency is greater than the treatment period.
Explanation of Visits and Timing of Assessments:
Baseline assessment was performed for all subjects during the screening period. On the first day of treatment, the first week after treatment (± 2 days), the second week (± 2 days), the 4th week (± 5 days), the 6th week (± 5 days), the 8th week (± 5 days),the 12th week (± 5 days), the 16th week (± 5 days) for visit.The 3th week (± 2 days), the 5th week (± 5 days), the 7th week (± 5 days), the 10th week (± 5 days), the 14th week (± 5 days), for telephone interviews.
- Conditions
- Diabetes
- Being tested
- QS-M insulin-free injector, conventional insulin pen
- Keywords
- T2DM, QS-M needle free injector, insulin pen, effective, safety
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QS-M insulin-free injectorDevice
Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
conventional insulin penDevice
Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: conventional insulin pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 16weeks
Secondary outcomes (1)
Self-monitoring of blood glucose(SMBG)
SMBG blood glucose value (on the first day and two days before the 1st, 2nd, 4th, 6th, 8th, 12th, 16th weeks interview, test the values before and 2 hours after the three meals and before sleeping).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start18 Aug 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing QS Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Li Nong, Principal investigator, Peking University People 's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243903
- Sponsor's protocol ID
- KSE01
- Status last verified
- Mar 2020
- First submitted
- 6 Aug 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32529176Ji 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.
PubMed 31004325
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of QS-M Needle -Free Injector Versus Needle-insulin Pen as a Drug Carrier for Controlling the Blood Glucose in T2DM：a Randomized, Parallel Controlled, Open-label, Multicenter Trial
- ClinicalTrials.gov ID
- NCT03243903
- Acronym / sponsor ID
- KSE01
- Conditions
- Diabetes
- Keywords
- T2DM, QS-M needle free injector, insulin pen, effective, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Beijing QS Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 9 Aug 2017 (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.
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.
Detailed description
The research purpose is to evaluate the efficacy and safety of QS-M needle-free injector as a drug carrier in the control of blood glucose in patients with type 2 diabetes mellitus by non-inferiority study，using needle-insulin pen as the comparison. This is a prospective, multicenter, randomized, open and parallel grouping study. QS-M needle-free injector produced by Beijing QS medical technology co., Ltd.is used as the insulin carrier in the experimental group. While needle-insulin pen is used as the insulin carrier in the control group. In this study, the investigators investigated whether the changes of glycosylated hemoglobin (HbA1c) at the 16th week in the experimental group respected to the baseline is non-inferiority compared with that in control group. A total of 427 patients with T2DM were enrolled in a prospective, multicenter,randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks' treatment with basal insulin or premixed insulin administered either by a needle-free insulin injector (NFII)or insulin treatment via a conventional insulin pen (CIP)
Patients in both groups entered a 2-week screening period after providing their written informed consent. A run-in period from week 1 to the end of week 4 was implemented to allow treatment adjustment. Assessment visits occurred at screening (week -2), baseline, and week 1, 2, 4, 6, 8, 12 and 16.After the 4-week run-in phase, the patients entered a 12-week treatment observation period. All patients were unable to change the type of insulin and the number of injections during the study period. In this study, the treatment regimen was adjusted according to the results of the determination of prescription blood glucose. According to clinical experience, the adjustment of blood glucose fluctuations in the possibility of a larger, so the study of the adjustment phase follow-up frequency is greater than the treatment period.
Explanation of Visits and Timing of Assessments:
Baseline assessment was performed for all subjects during the screening period. On the first day of treatment, the first week after treatment (± 2 days), the second week (± 2 days), the 4th week (± 5 days), the 6th week (± 5 days), the 8th week (± 5 days),the 12th week (± 5 days), the 16th week (± 5 days) for visit.The 3th week (± 2 days), the 5th week (± 5 days), the 7th week (± 5 days), the 10th week (± 5 days), the 14th week (± 5 days), for telephone interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needle-free insulin injector | Experimental | Device: QS-M insulin-free injectorUsing QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed. |
| conventional insulin pen | Active comparator | Device: conventional insulin penUsing conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (19 listed)
- 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;
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 insulin-free injectorUsing QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed. | Device | needle-free insulin injector |
| conventional insulin penUsing conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed. | Device | conventional insulin pen |
Primary outcome
glycosylated hemoglobin (HbA1c)
Time frame: 16weeks
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) .
1 secondary outcome
Self-monitoring of blood glucose(SMBG)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 32529176Ji 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.
- Derived from this study: PubMed 31004325Ji 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.
- Individual participant dataSharing planned: No
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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.
Ji Li Nong principal investigator
Peking University People 's Hospital
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 insulin-free injector and conventional insulin pen in people with Diabetes, run by Beijing QS Medical Technology Co., Ltd. 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 27 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glycosylated hemoglobin (HbA1c) (time frame: 16weeks). 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 NCT03243903, which also lists 2 linked publications.
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 27 Mar 2020.