A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients On Metformin Treatment(SUPER-2)
NCT ID: NCT04998032
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
620 participants
INTERVENTIONAL
2021-10-12
2023-08-13
Brief Summary
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This trial includes dosage determination (Phase IIb) and efficacy confirmation stage(Phase III ). The primary outcome of the phase IIb period is to preliminarily evaluate the efficacy and safety of Supaglutide combined with metformin and to provide the recommended dosage for the Phase 3 period after 12-week treatment.
The primary outcome of the Phase III period is to evaluate the efficacy and safety of Supaglutide combined with metformin treatment after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide combined with metformin during the 24-week, double-blinded plus 28-week, open-label treatment period.
Detailed Description
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When the number of participants who have completed the 12-week follow up reached 120, interim analyses will be performed and the results will be evaluated by Independent Data Monitoring Committee experts to determine the recommended phase 3 dosage.
During the phase III stage, subjects were randomly assigned 1:1 to the "recommended phase 3 dosage + metformin" group and the "placebo + metformin" group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
When 120 subjects complete the 12 weeks of follow-up, Interim analysis will be performed and the results be evaluated by IDMC to confirm the RP3D dose.
And then during the phase III, subjects were randomly assigned to Supaglutide RP3D + metformin, placebo + metformin group according to a 1:1 ratio.
TREATMENT
DOUBLE
Study Groups
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supaglutide RP3D dose+metformin
Supaglutide Subcutaneous injection once a week for 52weeks,combined with metformin
supaglutide injection+metformin
supaglutide subcutaneous injection under RP3D dose combined with metformin treatment
placebo+metformin
Placebo Subcutaneous injection once a week for 52weeks,,combined with metformin
placebo+metformin
placebo subcutaneous injection combined with metformin treatment
Interventions
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supaglutide injection+metformin
supaglutide subcutaneous injection under RP3D dose combined with metformin treatment
placebo+metformin
placebo subcutaneous injection combined with metformin treatment
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Weiping Jia, M.D,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Locations
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Beijing Boai Hospital
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
Emergency General Hospital
Beijing, , China
Cangzhou Central Hospital
Cangzhou, , China
Cangzhou Hospital of Integrated TCM-WM Hebei
Cangzhou, , China
The Second Hospital of Jilin University
Changchun, , China
First People's Hospital of Changde
Changde, , China
Changsha Hopital Affiliated to Hunan University
Changsha, , China
The Fourth Hospital of Changsha
Changsha, , China
Chengdu Fifth People's Hospital
Chengdu, , China
Chenzhou First People's Hospital
Chenzhou, , China
Chongqing Ninth People's Hospital
Chongqing, , China
Dalian Municipal Central Hospital
Dalian, , China
Daqing People's Hospital
Daqing, , China
Jilin Guowen Hospital
Gongzhuling, , China
Handan First Hospital
Handan, , China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, , China
Heze Municipal Hospital
Heze, , China
Huai'an First People's Hospital
Huai'an, , China
Huai'an Second People's Hospital
Huai'an, , China
Huizhou Central Hospital
Huizhou, , China
Jilin People's Hospital
Jilin, , China
Jinan Central Hospital Affiliated to Shandong First Medical University
Jinan, , China
Jincheng General Hospital
Jincheng, , China
Jingzhou Central Hospital
Jingzhou, , China
The Second Affiliated Hospital of Kunming Medical University
Kunming, , China
The Second People's Hospital of Lianyungang
Lianyungang, , China
Linfen People's Hospital
Linfen, , China
First People's Hospital of Tancheng
Linyi, , China
Liuzhou People's Hospital
Liuzhou, , China
The First Affiliated Hospital of Henan University
Luoyang, , China
Meihekou Central Hospital
Meihekou, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Nanjing First Hospital
Nanjing, , China
Nanjing Jiangning Hospital
Nanjing, , China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, , China
Nanyang First People's Hospital
Nanyang, , China
Nanyang Second General Hospital
Nanyang, , China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, , China
Puyang Oilfield General Hospital
Pujiang, , China
The First Hospital of Qinhuangdao
Qinhuangdao, , China
The First Hospital of Qiqihar
Qiqihar, , China
Changhai Hospital
Shanghai, , China
Huadong Hospital
Shanghai, , China
Shanghai Pudong New Area People's Hospital
Shanghai, , China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, , China
Shanghai Tongren Hospital
Shanghai, , China
Siping Central Hospital
Siping, , China
Second Hospital of Shanxi Medical University
Taiyuan, , China
The Second Affiliated Hospital of Shandong First Medical University
Tanan, , China
The Second Hospital of Tanjin Medical University
Tianjin, , China
Tianjin Medical University General Hospital
Tianjing, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Jiangyin People's Hospital
Wuxi, , China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, , China
Xuzhou Cancer Hospital
Xuzhou, , China
The Second People's Hospital of Yibin
Yibin, , China
Yichun People's Hospital
Yichun, , China
Yiyang Central Hospital
Yiyang, , China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
First People's Hospital of Zunyi
Zunyi, , China
Countries
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References
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Wang Q, Jiang F, Xu Y, Lei Y, Zhang L, Sun X. Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Treated with Metformin. Clin Pharmacokinet. 2025 Sep 24. doi: 10.1007/s40262-025-01569-2. Online ahead of print.
Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17.
Other Identifiers
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YN011-302
Identifier Type: -
Identifier Source: org_study_id