Not yet recruitingPhase 3

A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes

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

Lead sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

510

Study population

Type 2 diabetes

Eligibility highlights

•BMI 19-40•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06559722

Org study IDTHDB0213L03

Timeline

Milestones

Study first posted2024-08-19actual

Last update posted2024-08-19actual

Study start2024-08estimated (month precision)

Primary completion2025-10estimated (month precision)

Study completion2026-02estimated (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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:

1. Metformin (≥ 1500 mg or at maximum tolerated dose) or

2. Metformin (≥1500 mg or max tolerated dose) and SU (≥half of the max approved dose according to local label) or

3. Metformin (≥1500 mg or max tolerated dose) and glinides (≥half of the max approved dose according to local label) or

4. Metformin (≥1500 mg or max tolerated dose) and AGI (≥half of the max approved dose according to local label) or

5. 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

6. 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.

Exclusion criteria

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);

•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.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight after 12, 26 weeks of treatment

Time frame:Baseline, Week 12, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change from baseline in HbA1c after 26 weeks of treatment

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment

Time frame:Week 12, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment

Time frame:Week 12, Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment

Time frame:Baseline, Week 12, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment

Time frame:Baseline, Week 12, Week 26

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:From Baseline to Week 27

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment emergent hypoglycaemic episodes

Time frame:From Baseline to Week 27

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of participants with injection site reactions

Time frame:From Baseline to Week 27

event count, event

Secondary/protocol endpoint

Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable)

Time frame:Baseline, Week 12, 26, and 27 (if applicable)

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Plasma concentrations of degludec, liraglutide

Time frame:Baseline, Week 2, 6, 12, 20, 26

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.