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

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

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Asset

Efsubaglutide Alfa

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c ≤7%

Primary endpoint

•Clinical remission rate of diabetes

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06605287

Org study IDKY20230310-07

Timeline

Milestones

Study start2023-03-13actual

Study first posted2024-09-20actual

Last update posted2024-09-20actual

Primary completion2024-12-31estimated

Study completion2025-12-31estimated

Assets

Investigational agents

Efsubaglutide Alfa

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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.

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body composition (%)

Time frame:48 weeks

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

The clinical remission rate of diabetes

Time frame:48 weeks

descriptive

Secondary/protocol endpoint

Concentration of C-peptide(ng/ml) changes

Time frame:48 weeks

concentration, descriptive

Secondary/protocol endpoint

Concentration of Insulin (mU/L) changes

Time frame:48 weeks

concentration, descriptive

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:48 weeks

change from baseline, improvement