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

Phase

N/A

Condition

Hypertriglyceridemia

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT06605287

KY20230310-07

Ages 18-75
All Genders

Study 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 .

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

The researchers believe that the subjects have a disease state where they cannotcomplete the observation period follow-up;
The researchers determined that there were situations in the subjects that affectedthe compliance of this study during the treatment with Supaglutide.

Study Design

March 13, 2023

December 31, 2025

Study Description

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.

Connect with a study center

Nanjing First Hospital, Nanjing Medical Univesity
Nanjing,
China
Active - Recruiting

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