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
1 other identifier
interventional
620
1 country
61
Brief Summary
This is a study to evaluate the efficacy and safety of Supaglutide injection in the treatment of type 2 diabetes patients with poor glycemic control after metformin treatment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
October 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2023
CompletedDecember 6, 2024
December 1, 2024
1.7 years
July 28, 2021
December 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
The change in mean HbA1c concentrations (%)from baseline with Supaglutide versus placebo
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
Secondary Outcomes (14)
fasting plasma glucose
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
HbA1c<7.0% and <6.5%
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
Fasting insulin
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
fasting C-peptide
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
fasting glucagon
12 weeks for phase IIb; 24weeks and 52 weeks for phase III
- +9 more secondary outcomes
Study Arms (2)
supaglutide RP3D dose+metformin
EXPERIMENTALSupaglutide Subcutaneous injection once a week for 52weeks,combined with metformin
placebo+metformin
PLACEBO COMPARATORPlacebo Subcutaneous injection once a week for 52weeks,,combined with metformin
Interventions
supaglutide subcutaneous injection under RP3D dose combined with metformin treatment
placebo subcutaneous injection combined with metformin treatment
Eligibility Criteria
You may qualify if:
- Male or female patients aged from 18 to 75;
- Clinical diagnosed of Type 2 diabetes for at least 8 weeks ，receive metformin single treatment ；
- During screening, HbA1c: 7.5% ≤ HbA1c ≤ 11% ，and before randomization 7.5% ≤ HbA1c ≤ 10.5%;
- During screening and before randomization: FPG\< 13.9 mmol/L； 5.18.5 kg/m2 ≤ BMI ≤ 35 kg/m2;
- \. without birth plan and voluntarily take effective contraceptive measures; 7. fully understood the study, signed the informed consent；
You may not qualify if:
- Diabetes other than Type 2;
- Any dipeptidyl peptidase IV and / or glucagon-like peptide-1 （GLP-1）analogues were used within 3 months before screening;
- Continuous use of insulin for more than 14 days in the previous year;
- C-Peptide \<0.3 nmol/L;
- Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;
- Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;
- Severe hypoglycemia occurred within 6 months before screening
- Severe trauma infection or operation within one month before screening;
- Blood donation or massive blood loss or transfusion within 3 months ;
- Suspected active infection ;
- Growth hormone therapy was performed within 6 months before screening;
- Patients having received corticosteroid continuous ≥ 7 days through within 2 months ;
- use any drugs or surgery with weight control effect within 2 months;
- weight change of more than 5% within 3 months;
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
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
Liuchow, 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
Related Publications (2)
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 Dec;64(12):1799-1809. doi: 10.1007/s40262-025-01569-2. Epub 2025 Sep 24.
PMID: 40991141DERIVEDLou 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.
PMID: 39961992DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Weiping Jia, M.D,Ph.D
Shanghai 6th People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This includes a 24-week double-blind treatment period, followed by a 28-week open-label treatment period.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 10, 2021
Study Start
October 12, 2021
Primary Completion
June 15, 2023
Study Completion
August 13, 2023
Last Updated
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share