An observational study in Type 2 Diabetes Mellitus, sponsored by Nanjing First Hospital, Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational
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 .
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 220 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Type 2 diabetes patients without any hypoglycemic drugs after 52 or 28 weeks of Supaglutide treatment
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
Time frame: 48 weeks
Concentration of MBG (mmol/L) changes
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
hange in TIR(%), TAR(%), TBR(%)
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
Change in MAGE
MAGE analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM
Time frame: 48 weeks
Change in CV
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(mmol/L), PBG(mmol/L) changes
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(ng/ml) changes
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 (mU/L) changes
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 (pmol/L) changes
Concentration of glucagon changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Change in HOMA-IR
HOMA-IR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Change in body composition (%)
Body composition analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Change in Dex bone density (T value)
Dex bone density analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
Time frame: 48 weeks
Plan to share: Undecided
Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.
Of 398 non-industry observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 89. This study's planned 21 months is below that.
Counting every sponsor, half of 562 studies reached it within 31 months; a quarter within 17 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Nanjing First Hospital, Nanjing Medical University →