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

Официальное название

A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients

Обзор

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 .

Подробное описание

With the rapid development of economy, the occurrence of diabetes in China has also shown a momentum of rapid growth. Dietary control and exercise are usually the foundation for treating T2DM. For patients whose glucose control does not meet the standard, hypoglycemic drugs should be added on the basis of diet control and exercise. 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. Supaglutide can activate GLP-1 receptor in pancreatic islets β cells to increase insulin secretion and inhibit glucagon release in a glucose dependent manner. 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, pancreatic islets β and α cell function, insulin resistance, changes in body composition, and blood glucose fluctuations of patients who stopped using Supaglutide for 3 months and 1 year.

Первичные конечные точки

• The clinical remission rate of diabetes [Срок оценки: 48 weeks]

Вторичные конечные точки (11)

• Concentration of MBG (mmol/L) changes [Срок оценки: 48 weeks]
• hange in TIR(%), TAR(%), TBR(%) [Срок оценки: 48 weeks]
• Change in MAGE [Срок оценки: 48 weeks]
• Change in CV [Срок оценки: 48 weeks]
• Concentration of FBG(mmol/L), PBG(mmol/L) changes [Срок оценки: 48 weeks]
• Concentration of C-peptide(ng/ml) changes [Срок оценки: 48 weeks]
• Concentration of Insulin (mU/L) changes [Срок оценки: 48 weeks]
• Concentration of glucagon (pmol/L) changes [Срок оценки: 48 weeks]
• Change in HOMA-IR [Срок оценки: 48 weeks]
• Change in body composition (%) [Срок оценки: 48 weeks]
• Change in Dex bone density (T value) [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Nanjing First Hospital, Nanjing Medical Univesity — Нанкин

Публикации

• 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 Mar;43(3):1098-1108. doi: 10.1007/s12325-025-03467-2. Epub 2026 Jan 7. PMID 41498879

Идентификаторы

NCT: NCT06605287 · KY20230310-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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