DelfaGLP-1 Atlas

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UnknownPhase 3

Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes

A Phase III,Randomized,Parallel,Open-label,Multicenter Trial to Compare the Efficacy and Safety of Liraglutide and Victoza® in Patients With Type 2 Diabetes Inadequately Controlled by Oral Metformin Alone

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

46

Recruiting sites

33

Enrollment

424

estimated

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-45•HbA1c 7-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04373967
Org study IDTQF2451-III-01

Timeline

Milestones

Study start2020-04-29actual
Study first posted2020-05-05actual
Last update posted2020-07-08actual
Primary completion2021-12-01estimated
Study completion2021-12-02estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed as type 2 diabetes.
•Stably daily dose of metformin alone[between the dose of 1500mg and 2000mg inclusive] for at least 12 weeks prior to day of screening .
•HbA1c(glycosylated haemoglobin) of 7-11%(both inclusive).
•Body mass index (BMI) of 18.5-45 kg/m2(both inclusive).
•The patient must give informed consent to the study before the trial and voluntarily sign the informed consent form.
•The patient can communicate well with the researcher and complete the study in accordance with the research regulations.

Exclusion criteria

•Diagnosed as type 1 or other types of diabetes.
•Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist, dipeptidyl peptidase-4 (DPP-4) inhibitor and insulin treatment within 3 months before screening.[short term (cumulative use ≤7 days) insulin therapy due to intermittent disease is excluded]
•Treatment with systemic glucocorticoid therapy within 3 months before screening[topical medication or inhaled product is excluded] .
•Treatment with Chinese medicine preparations having hypoglycemic effects within 1 month before screening.
•Patients with recurrent severe or unconscious hypoglycemia within 3 months before screening.
•Patients with acute metabolic complications (ketoacidosis, lactic acidosis or hypertonic coma, etc.) within 6 months before screening.
•History of chronic pancreatitis or idiopathic acute pancreatitis, or suffering from acute or chronic pancreatitis during screening, or blood amylase ≥ 3 times of the upper limit of normal value, or triglycerides ≥ 8.0 mmol / L.
•Fasting blood-glucose(FBG)≥15.0 mmol / L on the day of screening.
•Personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine adenoma (MEN2).
•Patients with obvious liver and kidney dysfunction (alanine aminotransferase (ALT)> 2.5 × upper normal value (ULN), aspartate aminotransferase (AST)> 2.5 ULN, glomerular filtration rate <60 Milliliter(mL) / min / 1.73m2
•Hemoglobin <lower limit of normal value.
•Hyperthyroidism is being treated or the dosage of hypothyroidism is not stable within 6 months.
•Uncontrolled or poorly treated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
•Patients with decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or vascular reconstruction performed (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months before screening.
•Proliferative retinopathy or macular disease (macular edema) that requires urgent treatment.
•Malignant tumors (except basal cell carcinoma or phosphorous cell skin cancer) diagnosed within the past 5 years.
•Patients with severe chronic gastrointestinal disease (such as active peptic ulcer) and severe infections.
•People who are allergic to any of the ingredients in metformin, liraglutide injection and Victoza®.
•Participated in any other clinical trials within 3 months before screening.
•Pregnant women, lactating women and women of reproductive age who did not take appropriate contraception (sterilization, intrauterine devices, oral contraceptives or barrier contraception) during the trial.
•History of psychotropic substance abuse, alcohol abuse or drug addiction.
•Patients judged as unsuitable participants of the trial by researchers or with poor compliance.
•According to the investigators' judgment, there are seriously concomitant diseases endanger the safety of the patient or prevent the patient from completing the study.

Endpoints (15)

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
7
Safety / tolerability / PK
5
Cardiometabolic biomarkers
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:week 0,week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

glycated hemoglobin (HbA1c)

Time frame:week 0,week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of achieving HbA1c target (<7.0% or ≤6.5%)

Time frame:week 0,week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c change from baseline

Time frame:week 0,week 14

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes in fasting venous blood glucose (FPG).

Time frame:week 0,week 14,week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes in 2h-Postprandial Blood Glucose(2h-PBG).

Time frame:week 0,week 14,week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in fasting insulin.

Time frame:week 0,week 14,week 26

change from baseline, improvement

Secondary/protocol endpoint

Changes in fasting C peptide.

Time frame:week 0,week 14,week 26

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Changes in systolic blood pressure.

Time frame:week 0,week 14,week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Changes in diastolic blood pressure.

Time frame:week 0,week 14,week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number of adverse events and serious adverse events during exposure to trail product.

Time frame:week 0-26

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trail product.

Time frame:week 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Positive rate of liraglutide anti-drug antibody(ADA).

Time frame:week 0-26

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Percentage of participants with clinically significant change from baseline in vital signs.

Time frame:week 0-26

descriptive

Secondary/protocol endpoint

Percentage of participants with clinically significant change from baseline in laboratory parameters.

Time frame:week 0-26

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.