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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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
Weight & body composition
1 endpointweight
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
Glycemic / diabetes
8 endpointsHbA1c
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
fasting plasma glucose
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
concentration, descriptive
HbA1c<7.0% and <6.5%
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
Fasting insulin
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
fasting C-peptide
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
Area under the curve of blood glucose
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
Area under the curve of insulin
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
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 endpointsTotal cholesterol
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
triglyceride
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
Other (unclassified)
4 endpointsfasting glucagon
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
low density lipoprotein
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
High density lipoprotein
Time frame:12 weeks for phase IIb; 24weeks and 52 weeks for phase III
descriptive
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.
Registry references + supporting bibliography
- PMID39961992via clinicaltrials gov reference derived
- PMID42103705via clinicaltrials gov reference derived
- PMID40991141via clinicaltrials gov reference derived
Provenance
Sources
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.