Clinical trial NCT06605287: The Progress of Diabetes After Supaglutide Treatment in Type 2 Diabetes Patients
Official title: A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Keywords: clinical remission
Supaglutide
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The clinical remission rate of diabetes
timeFrame: 48 weeks
Secondary outcomes:
measure: Concentration of MBG (mmol/L) changes
timeFrame: 48 weeks
measure: hange in TIR(%), TAR(%), TBR(%)
timeFrame: 48 weeks
measure: Change in MAGE
timeFrame: 48 weeks
measure: Change in CV
timeFrame: 48 weeks
measure: Concentration of FBG(mmol/L), PBG(mmol/L) changes
timeFrame: 48 weeks
measure: Concentration of C-peptide(ng/ml) changes
timeFrame: 48 weeks
measure: Concentration of Insulin (mU/L) changes
timeFrame: 48 weeks
measure: Concentration of glucagon (pmol/L) changes
timeFrame: 48 weeks
measure: Change in HOMA-IR
timeFrame: 48 weeks
measure: Change in body composition (%)
timeFrame: 48 weeks
measure: Change in Dex bone density (T value)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical Univesity
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Jianhua Ma
role: PRINCIPAL_INVESTIGATOR
References: