The Progress of Diabetes After Supaglutide Treatment in Type 2 Diabetes Patients

NCT06605287 | Recruiting DMC

• 1 other identifier: KY20230310-07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Glucagon like peptide-1 receptor agonist (GLP-1RA) can enhance insulin secretion and inhibit glucagon secretion in a glucose concentration dependent manner, delay gastric emptying, and reduce food intake through central appetite inhibition, thus achieving the effect of lowering glucose. Supaglutide Injection (YN-011, Diabegone®) has the characteristic of high affinity with GLP-1 receptors. Previous studies by Weng Jianping had shown that early use of short-term insulin fortification and oral medication (sulfonylureas and metformin) fortification therapy for newly diagnosed T2DM still resulted in clinical remission in about 50% of patients one year after discontinuation of medication, i.e. no hypoglycemic drugs were used, only diet and exercise therapy were maintained. At the same time, early fortification therapy can promote pancreatic islets β Cell repair. At present, there are few studies on the clinical remission rate of diabetes after GLP-1RA hypoglycemic treatment for one year. This study aims to discontinue the use of Supaglutide treatment after 52 or 28 weeks, and continue a one-year non pharmacological intervention observation to observe the clinical remission rate of diabetes, the changes in pancreatic islets β and α cell function, insulin resistance, body composition, and blood glucose fluctuations of patients who stopped using Supaglutide for 3 months and 1 year .

Conditions

Type 2 Diabetes Mellitus

Keywords

clinical remission; Supaglutide

Outcome Measures

Primary Outcomes (1)

• The clinical remission rate of diabetes

  Concentration of HbA1c changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  48 weeks

Secondary Outcomes (11)

• Concentration of MBG (mmol/L) changes

  48 weeks

• hange in TIR(%), TAR(%), TBR(%)

  48 weeks

• Change in MAGE

  48 weeks

• Change in CV

  48 weeks

• Concentration of FBG(mmol/L), PBG(mmol/L) changes

  48 weeks

Study Arms (1)

Supaglutide Treatment

Type 2 diabetes patients without any hypoglycemic drugs after 52 or 28 weeks of Supaglutide treatment

Eligibility Criteria

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

Study Population

In this study, subjects with type 2 diabetes treated with Supaglutide were screened to meet the target of glucose control when they completed 52 or 28 weeks of Supaglutide treatment respectively.

You may qualify if:

• Complete a multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy of Supaglutide in T2DM patients with poor glucose control after dietary and exercise interventions (YN011-301);
• HbA1c ≤ 7.0%;
• The researchers determined that the patient's glucose control was stable based on the visit data of the subjects during the treatment with Supaglutide and the testing indicators of our hospital;
• The subjects agree to maintain scientific dietary and exercise habits throughout the entire research process, regularly conduct SMBG and keep records;
• Able to understand and willing to sign a written informed consent form and comply with the research protocol.

You may not qualify if:

• The researchers believe that the subjects have a disease state where they cannot complete the observation period follow-up;
• The researchers determined that there were situations in the subjects that affected the compliance of this study during the treatment with Supaglutide.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

RECRUITING

Related Publications (1)

• Sun R, Wang K, Yuan G, Shi B, Wang X, Shao A, Xu Y, Wang Q, Ma J. Diabetes Remission in Drug-Naive Patients with Type 2 Diabetes After Efsubaglutide Alfa Treatment. Adv Ther. 2026 Jan 7. doi: 10.1007/s12325-025-03467-2. Online ahead of print.

  PMID: 41498879 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect serum samples for cytokine detection

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jianhua Ma

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Ma

CONTACT

+8618951670116; majianhua196503@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: September 20, 2024
• Study Start: March 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-08

Locations

CN (1)