Type 2 Diabetes Mellitus
Conditions
Keywords
clinical remission, Supaglutide
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 .
Detailed 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.
Interventions
None listed
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinical remission rate of diabetes | 48 weeks | Concentration of HbA1c changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hange in TIR(%), TAR(%), TBR(%) | 48 weeks | TIR, TAR, TBR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM |
| Change in MAGE | 48 weeks | MAGE analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM |
| Change in CV | 48 weeks | CV analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM |
| Concentration of FBG(mmol/L), PBG(mmol/L) changes | 48 weeks | Concentration of FBG, PBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Concentration of C-peptide(ng/ml) changes | 48 weeks | Concentration of C-peptide changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Concentration of MBG (mmol/L) changes | 48 weeks | Concentration of MBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM |
| Concentration of glucagon (pmol/L) changes | 48 weeks | Concentration of glucagon changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Change in HOMA-IR | 48 weeks | HOMA-IR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Change in body composition (%) | 48 weeks | Body composition analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Change in Dex bone density (T value) | 48 weeks | Dex bone density analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
| Concentration of Insulin (mU/L) changes | 48 weeks | Concentration of Insulin changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment |
Countries
China
Contacts
Primary ContactJianhua Ma
Outcome results
None listed