A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients

Status: Recruiting
Location: See location...
Study Type: Observational
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanjing First Hospital, Nanjing Medical Univesity
RECRUITING
Nanjing
Contact Information
Primary
Jianhua Ma
majianhua196503@126.com
+8618951670116
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Supaglutide Treatment
Type 2 diabetes patients without any hypoglycemic drugs after 52 or 28 weeks of Supaglutide treatment
Related Therapeutic Areas
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov