Metformin in Post Chronic Pancreatitis Diabetes Mellitus

Launched by CHANGHAI HOSPITAL · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called metformin to help control blood sugar levels in people who have developed diabetes after chronic pancreatitis, a condition that affects the pancreas. The main goals are to see how well metformin works in managing blood sugar and to find out if there are any side effects associated with its use. Participants will be randomly assigned to receive either metformin or a placebo (a pill that looks like the medication but has no active ingredients) to determine the effectiveness and safety of the treatment.

To be eligible for this trial, participants should be between 18 and 65 years old and have been diagnosed with chronic pancreatitis and diabetes for at least three months. They should not have used any diabetes medications for at least eight weeks before joining the study. Participants can expect to take either metformin or a placebo and will be monitored for their blood sugar levels and any side effects during the trial. This study is not yet recruiting participants, so it's a good time to learn more about it if you or someone you know might be interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-65 years, any sex.
• • 2. Patients diagnosed with chronic pancreatitis.
• • 3. Diagnose diabetes at least 3 months after chronic pancreatitis diagnosis.
• • 4. Never used any diabetes drug/glucoselowering medication or had discontinued any glucoselowering medications for at least 8 weeks prior to screening.
• • 5. HbA1c criteria: 7.5%\~9.0%.
• • 6. BMI \>18.5.
• • 7. Provision of signed informed consent.
• Exclusion Criteria:
• • 1. Type 1 diabetes or secondary diabetes not caused by chronic pancreatitis (e.g. diabetes due to monogenic defects, cystic fibrosis, medications, autoimmune diseases, stress, or other factors).
• • 2. Contraindications or history of intolerance or allergy to metformin.
• • 3. Fasting C-peptide \<0.3 nmol/L.
• • 4. Acute episodes of chronic pancreatitis at enrollment or within 3 months prior to enrollment.
• • 5. History of congestive heart failure (NYHA class 3 or greater), unstable angina, or other severe cardiovascular diseases.
• • 6. History of cancer (except non-melanoma skin cancer) within 5 years prior to screening.
• • 7. History of partial or total pancreatectomy.
• • 8. History of or planning bariatric surgery.
• • 9. Previous organ transplantation.
• • 10. Treatment with oral or systemic glucocorticoids within 3 months prior to enrollment or plan to use during the study (inhaled steroids are permitted).
• • 11. History of hemolytic anemia, chronic transfusion requirements, or other conditions rendering HbA1c results unreliable.
• • 12. Other conditions requiring glucose-lowering medications, such as polycystic ovary syndrome.
• • 13. Fasting blood glucose \>11.1 mmol/L during screening, requiring immediate treatment as judged by the physician.
• • 14. Sever psychiatric disorders or health conditions deemed unsuitable for clinical research participation.
• • 15. Pregnancy or plans for pregnancy during the course of the study.
• • 16. Any other condition considered by the investigator to be inappropriate for participation in the trial.