Type 2 DiabetesPhase 3NCT06559722
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes
A Phase 3 study testing Insulin Degludec/liraglutide Injection and XULTOPHY® in people with Type 2 Diabetes, run by Tonghua Dongbao Pharmaceutical Co.,Ltd.
Trial summary
This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin Degludec/liraglutide Injection and XULTOPHY®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily participate in this clinical trial and signed the informed consent form (ICF);
- Chinese subjects aged 18-75 years (both inclusive) at the time of consent, male or female;
- Type 2 diabetes mellitus (clinically diagnosed for more than 6 months);
- HbA1c7.0-10.0 % (both inclusive) by central laboratory analysis at the time of screening;
- Current treatment for at least 90 calendar days prior to screening with metformin monotherapy or metformin in any combination with 1 additional OADs (including fixed combination): SU, glinides, AGI, SGLT2i or TZD. For ≥ 60 calendar days prior to screening subjects should be on a stable dose of:
- Metformin (≥ 1500 mg or at maximum tolerated dose) or
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- Metformin (≥1500 mg or max tolerated dose) and SU (≥half of the max approved dose according to local label) or
- Metformin (≥1500 mg or max tolerated dose) and glinides (≥half of the max approved dose according to local label) or
- Metformin (≥1500 mg or max tolerated dose) and AGI (≥half of the max approved dose according to local label) or
- Metformin (≥1500 mg or max tolerated dose) and SGLT2i (≥half of the max approved dose or minimum maintenance dose such as empagliflozin 10 mg and canagliflozin 100 mg according to local label) or
- Metformin (≥1500 mg or max tolerated dose) and TZD (≥half of the max approved dose according to local label);
- Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 40 kg/m2;
- Able and willing to adhere to the protocol including performing self-monitoring of plasma glucose profiles, keeping a trial diary and using a pre-filled pen device.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Subjects with diabetes of other types than T2DM;
- Known or suspected hypersensitivity to trial product(s) or related components;
- Participated in any clinical trial and Receipt of any treatment of investigational medicinal product (IMP) or medical device within 90 days prior screening;
- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria 5 for cumulatively more than 14 days in a period of 90 days before screening; or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy of glycemic control (Judged by the investigator);
- Treatment with systemic corticosteroid for cumulatively more than 14 days in a period of 90 days before screening (including intravenous, muscle and subcutaneous injections, and oral administration, except for local, intraocular, nasal, intraarticular, and inhalation medications); or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy (Judged by the investigator);
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- Treatment with glucose lowering agent(s) of herbal traditional Chinese medicine or other local herbal medicines for cumulatively more than 14 days in a period of 90 days before screening; or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy (Judged by the investigator);
- Treated with stable insulin regimen (except for short-term treatment (e.g., no more than 14 days of continuous treatment)), or treatment with insulin in a period of 30 days before screening and might influence the assessment of efficacy (Judged by the investigator);
- Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within 90 calendar days prior to screening;
- Impaired liver function, defined as aspart aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times upper limit of the normal or a total bilirubin level (TBIL) ≥ 1.5 times upper limit of the normal;
- Triglycerides >5.6 mmol/L at screening;
- Impaired renal function, defined as creatinine clearance (Ccr) of less than 60 mL/min (calculated from the Cockcroft-Gault formula);
- Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.
- Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.
- With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.
About this study
Official title: A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes
This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin Degludec/liraglutide Injection, XULTOPHY®
- 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/liraglutide InjectionDrug
Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.
XULTOPHY®Drug
Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Degludec/liraglutide injection | Experimental | Subcutaneously (s.c., under the skin) administration once daily in combination with metformin. Dose was individually adjusted. Receives: Drug: Insulin Degludec/liraglutide Injection |
| XULTOPHY® | Active comparator | Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. Receives: Drug: XULTOPHY® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c after 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Measured: Baseline, Week 26
Secondary outcomes (10)
Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Measured: Week 12, Week 26
Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Measured: Week 12, Week 26
Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment
Calculated based on FPG level measured in plasma
Measured: Baseline, Week 12, Week 26
Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment
Calculated based on 7-point SMBG values
Measured: Baseline, Week 12, Week 26
Change from baseline in body weight after 12, 26 weeks of treatment
Calculated based on body weight measurement
Measured: Baseline, Week 12, Week 26
Number of treatment emergent adverse events
Count
Measured: From Baseline to Week 27
Number of treatment emergent hypoglycaemic episodes
Count
Measured: From Baseline to Week 27
Number of participants with injection site reactions
Count (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Measured: From Baseline to Week 27
Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable)
Calculated based on the values of anti-drug antibodies (ADA), and neutralising antibodies (if applicable)
Measured: Baseline, Week 12, 26, and 27 (if applicable)
Plasma concentrations of degludec, liraglutide
Calculated based on plasma concentrations of degludec, liraglutide
Measured: Baseline, Week 2, 6, 12, 20, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (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.
- 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
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559722
- Sponsor's protocol ID
- THDB0213L03
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06559722
- Acronym / sponsor ID
- THDB0213L03
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Tonghua Dongbao Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Aug 2024 (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 is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Degludec/liraglutide injection | Experimental | Drug: Insulin Degludec/liraglutide InjectionSubcutaneously (s.c., under the skin) administration once daily in combination with metformin. Dose was individually adjusted. |
| XULTOPHY® | Active comparator | Drug: XULTOPHY®Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who voluntarily participate in this clinical trial and signed the informed consent form (ICF);
- Chinese subjects aged 18-75 years (both inclusive) at the time of consent, male or female;
- Type 2 diabetes mellitus (clinically diagnosed for more than 6 months);
- HbA1c7.0-10.0 % (both inclusive) by central laboratory analysis at the time of screening;
- Current treatment for at least 90 calendar days prior to screening with metformin monotherapy or metformin in any combination with 1 additional OADs (including fixed combination): SU, glinides, AGI, SGLT2i or TZD. For ≥ 60 calendar days prior to screening subjects should be on a stable dose of:
Key exclusion criteria (15 listed)
- Subjects with diabetes of other types than T2DM;
- Known or suspected hypersensitivity to trial product(s) or related components;
- Participated in any clinical trial and Receipt of any treatment of investigational medicinal product (IMP) or medical device within 90 days prior screening;
- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria 5 for cumulatively more than 14 days in a period of 90 days before screening; or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy of glycemic control (Judged by the investigator);
- Treatment with systemic corticosteroid for cumulatively more than 14 days in a period of 90 days before screening (including intravenous, muscle and subcutaneous injections, and oral administration, except for local, intraocular, nasal, intraarticular, and inhalation medications); or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy (Judged by the investigator);
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/liraglutide InjectionSubcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. | Drug | Insulin Degludec/liraglutide injection |
| XULTOPHY®Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. | Drug | XULTOPHY® |
Primary outcome
Change from baseline in HbA1c after 26 weeks of treatment
Time frame: Baseline, Week 26
Calculated based on HbA1c level measured in plasma
10 secondary outcomes
Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment
Time frame: Week 12, Week 26
Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment
Time frame: Week 12, Week 26
Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment
Time frame: Baseline, Week 12, Week 26
Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment
Time frame: Baseline, Week 12, Week 26
Change from baseline in body weight after 12, 26 weeks of treatment
Time frame: Baseline, Week 12, Week 26
Number of treatment emergent adverse events
Time frame: From Baseline to Week 27
Number of treatment emergent hypoglycaemic episodes
Time frame: From Baseline to Week 27
Number of participants with injection site reactions
Time frame: From Baseline to Week 27
Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable)
Time frame: Baseline, Week 12, 26, and 27 (if applicable)
Plasma concentrations of degludec, liraglutide
Time frame: Baseline, Week 2, 6, 12, 20, 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Degludec/liraglutide Injection and XULTOPHY® in people with Type 2 Diabetes, run by Tonghua Dongbao Pharmaceutical Co.,Ltd.
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 13 inclusion and 15 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 from baseline in HbA1c after 26 weeks of treatment (time frame: Baseline, Week 26). 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 19 Aug 2024.