Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06605287

The Progress of Diabetes After Supaglutide Treatment in Type 2 Diabetes Patients

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-09-20

100

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

The Progress of Diabetes After Supaglutide Treatment in Type 2 Diabetes Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Completed a multicenter, randomized, double-blind, placebo-controlled study on Supaglutide efficacy in T2DM patients with poor glucose control after diet and exercise
  • HbA1c less than or equal to 7.0%
  • Stable glucose control as determined by researchers during Supaglutide treatment
  • Agree to maintain scientific diet and exercise habits, regularly monitor blood glucose and keep records
  • Able to understand, willing to sign informed consent, and comply with study protocol
Not Eligible

You will not qualify if you...

  • Have a disease or condition that prevents completing the follow-up observation period
  • Situations affecting study compliance during Supaglutide treatment as determined by researchers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

Actively Recruiting

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Research Team

J

Jianhua Ma

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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