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Delfa

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CompletedPhase 2, PHASE3

A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients On Metformin Treatment(SUPER-2)

Efficacy and Safety of Once-weekly Supaglutide Versus Placebo in Patients With Type 2 Diabetes Suboptimally Controlled on Metformin: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Asset

Efsubaglutide Alfa

Subcutaneous · GLP-1 agonist

Listed sites

61

Recruiting sites

-

Actual enrollment

620

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤35•HbA1c ≤11%

Primary endpoint

•HbA1c

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 IDNCT04998032
Org study IDYN011-302

Timeline

Milestones

Study first posted2021-08-10actual
Study start2021-10-12actual
Primary completion2023-06-15actual
Study completion2023-08-13actual
Last update posted2024-12-06actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female patients aged from 18 to 75;

2. Clinical diagnosed of Type 2 diabetes for at least 8 weeks ,receive metformin single treatment ;

3. During screening, HbA1c: 7.5% ≤ HbA1c ≤ 11% ,and before randomization 7.5% ≤ HbA1c ≤ 10.5%;

4. During screening and before randomization: FPG< 13.9 mmol/L; 5.18.5 kg/m2 ≤ BMI ≤ 35 kg/m2;

6. without birth plan and voluntarily take effective contraceptive measures; 7. fully understood the study, signed the informed consent;

Exclusion criteria

1. Diabetes other than Type 2;

2. Any dipeptidyl peptidase IV and / or glucagon-like peptide-1 (GLP-1)analogues were used within 3 months before screening;

3. Continuous use of insulin for more than 14 days in the previous year;

4. C-Peptide <0.3 nmol/L;

5. Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;

6. Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;

7. Severe hypoglycemia occurred within 6 months before screening

8. Severe trauma infection or operation within one month before screening;

9. Blood donation or massive blood loss or transfusion within 3 months ;

10. Suspected active infection ;

11. Growth hormone therapy was performed within 6 months before screening;

12. Patients having received corticosteroid continuous ≥ 7 days through within 2 months ;

13. use any drugs or surgery with weight control effect within 2 months;

14. weight change of more than 5% within 3 months;

15. mean systolic pressure (SBP) ≥ 160mmhg and / or diastolic pressure (DBP) ≥ 90 mmHg at screening, or new/changed antihypertensive drugs or adjusted dosage of antihypertensive drugs within 4 weeks before screening or before induction period

16. with a history of severe cardiovascular disease, high risk of stroke/stroke within 6 months before screening;

17. with a history of acute or chronic pancreatitis, symptomatic gallbladder , pancreatic injury and other risk factors for pancreatitis, or with blood amylase and/or blood lipase ≥1.5 times the upper limit of normal (ULN) at the time of screening or before randomization;

18. Calcitonin level ≥50 ng/L (pg/mL) during screening;

19. with a history of medullary thyroid cancer, multiple endocrine neoplasm (Men) 2A or 2B syndrome, or related family history;

20. with clinically significant abnormal gastric emptying , severe chronic gastrointestinal diseases , long-term use of drugs that have a direct impact on gastrointestinal peristalsis , or having undergone gastrointestinal surgery within 6 months before screening, are not suitable to participate in this clinical study according to the evaluation of the researchers;

21. suffering from hematological diseases or any disease causing hemolysis or erythrocyte instability ;

22. Uncontrolled hyperthyroidism or hypothyroidism;

23. with hemoglobinopathy that may affect the determination of HbA1c levels;

24. HBsAg, Hepatitis C antibody, HIV-Ab, Treponema pallidum antibody or Corona Virus Disease 2019 nucleic acid tested positive;

25. serious mental illness;

26. drinking more than 14 standard units weekly within 6 months before screening ;

27. a history of organ transplantation or other acquired or congenital immune system diseases;

28. allergic to the active ingredients (GLP-1 and GLP-1 analogues) of the study drug;

29. clear contraindications for the use of metformin;

30. clear contraindications for Empagliflozin;

31. Any of the following conditions: the pacemaker was installed when screened; no pacemaker was installed, but 12 lead ECG showed degree II or III atrioventricular block, long QT syndrome or QTc interval ≥ 450ms ; Patients with New York Heart Function Classification III or IV; Or other abnormal cardiac function with clinical significance that is not suitable for clinical research judged by researchers;

32. acute or chronic hepatitis, or whose laboratory examination indexes meet one of the following criteria at the time of screening or before randomization : alanine aminotransferase (ALT) level ≥ 2.5 fold ULN, aspartate aminotransferase (AST) ≥ 2.5 fold ULN, fasting triglyceride (TG) > 5.7 mmol/L or 500 mg/dl; the glomerular filtration rate (EGFR) < 60 ml/min/1.73 square meters was calculated by CKD-EPI (epi - (SCR)) formula;

33. participated in clinical trials of other drugs or devices within 3 months before screening;

34. Medication compliance in the metformin dosage stable period was < 80% or > 120%;

35. Supaglutide placebo injection compliance during the induction period was <75% or>125%, or metformin compliance <80% or >120%;

36. Any other situation that researchers think may affect the patients' informed consent or compliance with the trial protocol;

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
8
Other (unclassified)
4
Cardiometabolic biomarkers
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

weight

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

HbA1c

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

fasting plasma glucose

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

concentration, descriptive

Secondary/protocol endpoint

HbA1c<7.0% and <6.5%

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

Fasting insulin

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

fasting C-peptide

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

Area under the curve of blood glucose

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

Area under the curve of insulin

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

Area under the curve of C-peptide

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Total cholesterol

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint

triglyceride

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

fasting glucagon

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint/low confidence

low density lipoprotein

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint/low confidence

High density lipoprotein

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Secondary/protocol endpoint/low confidence

salvage treatment

Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.