A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients(SUPER-1)

NCT04994288 | Completed Phase 2 DMC

• 1 other identifier: YN011-301
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 1

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 diet and exercise intervention. 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 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 after 24-week, double-blind treatment. The secondary outcome is to evaluate the efficacy and safety of Supaglutide after 24-week, double-blinded plus 28-week, open-label treatment period.

Conditions

Type2 Diabetes

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 (11)

• FPG

  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

Study Arms (3)

Supaglutide RP3D high dose

EXPERIMENTAL

during the IIb phase 140 subjects were randomly assigned to supaglutide 1mg, 2mg ,3mg and placebo ; when these subjects meets the 12wks HbA1C result, an interim analysis will be made andRP3D high dose is confirmed by IDMC accoding to interim analysis. So during the phase 3 , subjets will be assigned to RP3D hign dose, RP3D low dose and placebo

Biological: Supaglutide injection

supaglutide RD3D Low dose

EXPERIMENTAL

during the IIb phase 140 subjects were randomly assigned to supaglutide 1mg, 2mg ,3mg and placebo ; when these subjects meets the 12wks HbA1C result, an interim analysis will be made and RP3D high dose is confirmed by IDMC accoding to interim analysis. So during the phase 3, subjets will be assigned to RP3D hign dose, RP3D low dose and placebo

Biological: Supaglutide injection

placebo

PLACEBO COMPARATOR

placebo injection

Other: placebo injection

Interventions

Supaglutide injection BIOLOGICAL

Supaglutide 1mg/0.5ml , 2mg/0.5ml ,3mg /0.5ml

Supaglutide RP3D high dose; supaglutide RD3D Low dose

placebo injection OTHER

placebo injection 0.5ml

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged from 18 to 75;
• Type 2 diabetes diagonsed at least 8 weeks and has not received any glucose-lowering medication within 8 weeks prior to screening;
• During screening, HbA1c: 7.5% ≤ HbA1c ≤ 11%;
• Before randomization : 7.5% ≤ HbA1c ≤ 10.5%;
• During screening and before randomization: FPG\< 13.9 mmol/L
• kg/m2 ≤ BMI ≤ 35 kg/m2;
• without birth plan and voluntarily take effective contraceptive measures;
• fully understood the study, voluntarily entered the study and signed the informed consent.

You may not qualify if:

• Diabetes other than Type 2;
• Any DPP-4 inhibitors and / or 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 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

Sponsors & Collaborators

• Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Related Publications (3)

• Zhu D, Ma J, Wang W, Shi B, Dong X, Bian F, Li Q, Wang Y, Jiang C, Wang X, Wang K, Ling H, Shi X, Cheng Z, Yuan G, Li L, Su X, Lu Y, Song W, Zhang Y, Hu W, Zhang X, Wang H, Liu Y, Li J, Zhang L, Liu Y, Sun X, Wang X, Zhang K, Zhao Y, Zhang L, Pan T, Li P, Li S, Zhou H, Jiang C, Zheng X, Ni L, Feng B, Li F, Piao L, Jin H, Liu Y, Cao H, Li Y, Cai H, Mao H, Liang Y, Guo J, Wang Y, Li Y, Xu N, Zhang J, Zhang Q, Pang W, Yu J, Xu Y, Zhou Y, Li Y, Wang Q. Efficacy and safety of efsubaglutide alfa in individuals with type 2 diabetes (SUPER1): a randomised, double-blind, placebo-controlled, Phase IIb/III trial. Diabetologia. 2025 Nov 21. doi: 10.1007/s00125-025-06593-2. Online ahead of print.

  PMID: 41272211 DERIVED

• Wang Q, Jiang F, Xu Y, Lei Y, Zhang L, Sun X. Exposure-Response Analysis of Efsubaglutide Alfa in Patients with Type 2 Diabetes Mellitus. Clin Pharmacokinet. 2025 Dec;64(12):1785-1797. doi: 10.1007/s40262-025-01570-9. Epub 2025 Oct 17.

  PMID: 41107649 DERIVED

• 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.

  PMID: 39961992 DERIVED

Study Officials

• Dalong Zhu, M.D,Ph.D

  Nanjing trum tower hospital affiliated to Nanjing university school of medizine

  PRINCIPAL INVESTIGATOR

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

Model Details: This clinical trial includes dosage determination (Phase IIb) and efficacy confirmation stage(Phase III ). Subjects were randomly assigned to once-weekly subcutaneously injected Supaglutide 1mg, 2mg, 3mg and placebo according to a 2:2:2:1 ratio. During the IIb period, after Interim analysis and IDMC confirmed the RP3D high and low doses, subjects were randomly assigned to Supaglutide RP3D high dose, RP3D low dose and placebo group according to a 2:2:1 ratio.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 6, 2021
• Study Start: August 3, 2021
• Primary Completion: June 20, 2023
• Study Completion: August 16, 2023
• Last Updated: August 7, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)