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NCT Number: NCT06605287

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

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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

Location status: Recruiting

Location contact

Jianhua Ma, Professor

CONTACT

[email protected]

+8618951670116 ext. 8625-52887091

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The clinical remission rate of diabetes

    Time frame: 48 weeks

    Concentration of HbA1c changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

Secondary outcomes

  1. Concentration of MBG (mmol/L) changes

    Time frame: 48 weeks

    Concentration of MBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM

  2. hange in TIR(%), TAR(%), TBR(%)

    Time frame: 48 weeks

    TIR, TAR, TBR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM

  3. Change in MAGE

    Time frame: 48 weeks

    MAGE analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM

  4. Change in CV

    Time frame: 48 weeks

    CV analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment by FGM

  5. Concentration of FBG(mmol/L), PBG(mmol/L) changes

    Time frame: 48 weeks

    Concentration of FBG, PBG changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  6. Concentration of C-peptide(ng/ml) changes

    Time frame: 48 weeks

    Concentration of C-peptide changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  7. Concentration of Insulin (mU/L) changes

    Time frame: 48 weeks

    Concentration of Insulin changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  8. Concentration of glucagon (pmol/L) changes

    Time frame: 48 weeks

    Concentration of glucagon changes in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  9. Change in HOMA-IR

    Time frame: 48 weeks

    HOMA-IR analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  10. Change in body composition (%)

    Time frame: 48 weeks

    Body composition analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

  11. Change in Dex bone density (T value)

    Time frame: 48 weeks

    Dex bone density analysis in type 2 diabetes patients without any hypoglycemic drugs for 48 weeks after Supaglutide treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhua Ma

CONTACT

[email protected]

+8618951670116 ext. 02552887091

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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