Type 2 DiabetesPhase 3NCT04955834
A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes
A Phase 3 study testing Insulin degludec injection and Tresiba® in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin degludec injection and Tresiba®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 2 sitesChina
- Study dates
- 27 Jul 2021to 31 Dec 2025
- Phase
- Phase 3
- 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
- Type 2 diabetes (diagnosed clinically) for at least 6 months.
- Aged ≥18 and ≤70 years old, male or female.
- Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
- HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
- Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m2.
- Patients must give informed consent to this study before the trial, and voluntarily sign an informed consent form.
- Patients who can communicate well with the investigator and can complete the study in accordance with the research regulations.
Who cannot join
- Diagnosed as type 1 diabetes or other types of diabetes.
- Patients who have received insulin therapy for more than 7 days within 3 months before screening .
- Patients who have received a thiazolidinedione (TZD) or GLP-1 receptor agonist within 3 months before screening.
- Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
- Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
- Patients with hypoglycemia who have recurring severe events with conscious and/or physical changes within 3 months before screening and need help from others.
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- Those who have experienced acute metabolic complications (ketoacidosis, lactic acidosis, or hyperosmolar coma, etc.) within 3 months before screening.
- Patients with obvious liver and kidney dysfunction.
- Hemoglobin <100g/L.
- When the virological test during the screening period shows that any of the following is met:
- HCV（hepatitis C virus） antibody is positive, and the HCV virus titer test value exceeds the upper limit of normal value; (2) HBsAg（Hepatitis B surface antigen） is positive and the HBV（hepatitis B virus） DNA test value exceeds the upper limit of normal; (3) HIV（human immunodeficiency virus） positive; (4) Active syphilis;
- 11. At the time of screening, there are thyroid diseases that have not been controlled with stable doses of drugs within 6 months, and the results of thyroid function tests during the screening period are abnormal and have clinical significance.
- 12. Uncontrolled or poorly treated high blood pressure.
- 13. Those with decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or blood vessel reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) occurred within 6 months before screening.
- 14. Those with proliferative retinopathy or macular degeneration (macular edema) that requires urgent treatment during screening.
- 15. Once diagnosed as malignant tumor (except for basal cell carcinoma or squamous cell skin cancer).
- 16. Patients with severe chronic gastrointestinal diseases (such as active peptic ulcer) and severe infections.
- 17. Those who are allergic to any ingredient in insulin deglu injection and Novota®.
- 18.Those who participated in any other clinical trials within 3 months before screening (excluding those who failed the screening or did not use study drugs for other reasons).
- 19. Pregnant women, lactating women, women of childbearing age who do not take appropriate contraceptive measures during the trial period (sterilization, intrauterine device, oral contraceptives or barrier contraception).
- 20. Those who are judged by the investigator to be unsuitable to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Zhiguang Zhou, Doctor, 0731-85294018, zhouzg@hotmail.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Qifu Li, Doctor, 023-89012755, liqifu@yeah.net
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes
This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin degludec injection, Tresiba®
- 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.
Insulin degludec injectionDrug
long-acting insulin
Tresiba®Drug
long-acting insulin
| Study group | Role | What they receive |
|---|---|---|
| Insulin degludec injection | Experimental | Insulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. Receives: Drug: Insulin degludec injection |
| Tresiba® | Active comparator | Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. Receives: Drug: Tresiba® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change value of glycosylated hemoglobin (HbA1c)
Change value of HbA1c from baseline following 26 weeks of therapy
Measured: Baseline and 26 weeks
Secondary outcomes (7)
Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%
Percentage of patients in each arm achieving HbA1c ≤7% or HbA1c ≤6.5% after 26 weeks of treatment.
Measured: Baseline, week 26
Change value of HbA1c
Change value of HbA1c from baseline following 14 weeks of therapy
Measured: Baseline, week 14
Change value of fasting blood glucose
Change value of fasting blood glucose following 14 and 26 weeks of therapy
Measured: Baseline, week 14, week 26
Adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs and their incidence during the 26-week treatment period, and then determine the correlation with the drug
Measured: Baseline to week 26
Hypoglycemia
Frequency of severe or symptomatic hypoglycemia during the 26-week treatment period
Measured: Baseline to week 26
Immunogenicity
The occurrence of immunogenicity during the 26-week treatment period by detecting Anti-Drug-Antibody(ADA).
Measured: Baseline, week 14, week 26
Abnormal findings
Abnormal findings during the 26-week treatment period，including abnormal findings of blood routine test，blood biochemical test as well as other abnormal laboratory findings.
Measured: Baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start27 Jul 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955834
- Sponsor's protocol ID
- TQF2409-III-01
- Status last verified
- Sep 2021
- First submitted
- 5 Jul 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04955834
- Acronym / sponsor ID
- TQF2409-III-01
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 2021 (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.
This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin degludec injection | Experimental | Drug: Insulin degludec injectionInsulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. |
| Tresiba® | Active comparator | Drug: Tresiba®Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes (diagnosed clinically) for at least 6 months.
- Aged ≥18 and ≤70 years old, male or female.
- Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
- HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
- Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m2.
Key exclusion criteria (21 listed)
- Diagnosed as type 1 diabetes or other types of diabetes.
- Patients who have received insulin therapy for more than 7 days within 3 months before screening .
- Patients who have received a thiazolidinedione (TZD) or GLP-1 receptor agonist within 3 months before screening.
- Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
- Patients who are receiving or have received chronic (lasting more than 2 weeks) systemic glucocorticoid therapy (excluding topical drugs and inhaled preparations) within 3 months before the random visit.
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 |
|---|---|---|
| Insulin degludec injectionlong-acting insulin | Drug | Insulin degludec injection |
| Tresiba®long-acting insulin | Drug | Tresiba® |
Primary outcome
Change value of glycosylated hemoglobin (HbA1c)
Time frame: Baseline and 26 weeks
Change value of HbA1c from baseline following 26 weeks of therapy
7 secondary outcomes
Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5%
Time frame: Baseline, week 26
Change value of HbA1c
Time frame: Baseline, week 14
Change value of fasting blood glucose
Time frame: Baseline, week 14, week 26
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to week 26
Hypoglycemia
Time frame: Baseline to week 26
Immunogenicity
Time frame: Baseline, week 14, week 26
Abnormal findings
Time frame: Baseline to week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin degludec injection and Tresiba® in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 7 inclusion and 21 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Zhiguang Zhou, Doctor (0731-85294018, zhouzg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change value of glycosylated hemoglobin (HbA1c) (time frame: Baseline and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.