Nanjing First Hospital, Nanjing Medical Univesity
Nanjing, China
Location status: Recruiting
NCT Number: NCT06605287
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 .
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Nanjing, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 weeks
Concentration of HbA1c changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Concentration of MBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM
Time frame: 48 weeks
TIR, TAR, TBR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM
Time frame: 48 weeks
MAGE analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM
Time frame: 48 weeks
CV analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM
Time frame: 48 weeks
Concentration of FBG, PBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Concentration of C-peptide changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Concentration of Insulin changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Concentration of glucagon changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
HOMA-IR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Body composition analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Dex bone density analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Contact information is provided by the study sponsor or research team.
Nanjing First Hospital, Nanjing Medical University
Other
A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients
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