A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The clinical remission rate of diabetes
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The clinical remission rate of diabetes
时间窗: 48 weeks
Concentration of HbA1c changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment
次要结局
- Concentration of MBG (mmol/L) changes(48 weeks)
- hange in TIR(%), TAR(%), TBR(%)(48 weeks)
- Change in CV(48 weeks)
- Concentration of FBG(mmol/L), PBG(mmol/L) changes(48 weeks)
- Change in MAGE(48 weeks)
- Concentration of C-peptide(ng/ml) changes(48 weeks)
- Concentration of Insulin (mU/L) changes(48 weeks)
- Concentration of glucagon (pmol/L) changes(48 weeks)
- Change in HOMA-IR(48 weeks)
- Change in body composition (%)(48 weeks)
- Change in Dex bone density (T value)(48 weeks)