Effects of Supaglutide on Type 2 Diabetes Progression
A Study to Observe the Progress of Diabetes After Supaglutide Injection for 52 or 28 Weeks Treatment in Type 2 Diabetes Patients
This study is testing if Supaglutide can help people with Type 2 Diabetes who aren't controlling their blood sugar well with diet and exercise alone, by seeing if it can improve their diabetes after a year of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT06605287 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of Supaglutide, a GLP-1 receptor agonist, on the progression of Type 2 Diabetes Mellitus (T2DM) in patients who have not achieved adequate glucose control through diet and exercise alone. The study aims to assess the clinical remission rates of diabetes after one year of treatment with Supaglutide, focusing on its ability to enhance insulin secretion and inhibit glucagon release. Participants will be required to maintain a scientific dietary and exercise regimen throughout the study period, and their glucose control will be monitored closely. The study is based on previous findings that suggest early intervention can lead to significant improvements in diabetes management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with Type 2 Diabetes who have not achieved adequate glucose control through diet and exercise and have an HbA1c level of 7.0% or lower.
Not a fit: Patients with severe comorbid conditions that may prevent them from completing the study or those who cannot adhere to dietary and exercise protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into achieving clinical remission in Type 2 Diabetes patients, potentially reducing the need for ongoing medication.
How similar studies have performed: Previous studies have shown promising results with GLP-1 receptor agonists in managing Type 2 Diabetes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing
- Nanjing First Hospital, Nanjing Medical Univesity — Nanjing, China (Recruiting)
Study contacts
- Principal investigator: Jianhua Ma — Nanjing First Hospital, Nanjing Medical University
- Study coordinator: Jianhua Ma
- Email: majianhua196503@126.com
- Phone: +8618951670116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.