Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Outpatient newly diagnosed type 2 diabetes subjects; Drug: Inpatient newly diagnosed type 2 diabetes subjects

• Registration Number: NCT06825182
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-07
• Status Verified: 2025-02
• Study First Submitted: 2025-02-09
• Study First Submitted QC: 2025-02-09
• Last Update Submitted: 2025-02-09
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
• Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
• Subjects who are capable and willing to maintain a regular diet and exercise regimen.

Exclusion Criteria

• Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m^2;
• History of using blood sugar-lowering medications;
• Estimated glomerular filtration rate (eGFR) less than 30 ml/(min*1.73 m^2);
• History of drug abuse or alcohol dependence within the past 5 years;
• Patients with poor compliance and irregular diet and exercise;
• History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
• Patients who have used systemic glucocorticoid therapy within the past 3 months;
• Presence of infection or stress within the past four weeks;
• Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Loxenatide	Outpatient newly diagnosed type 2 diabetes subjects	-
Loxenatide	Inpatient newly diagnosed type 2 diabetes subjects	-

Primary Outcome Measures

Name	Time	Method
Glucagon levels	19 months	Compare the glucagon levels in diabetic subjects during hyperglycemia and hypoglycemia, and the changes in GCG after 3 months of GLP-1RA treatment

Trial Locations

Locations (1)

Nanjing First Hostital; 🇨🇳 Nanjing, Jiangsu, China