Metformin in Post Chronic Pancreatitis Diabetes Mellitus

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Chronic Pancreatitis

In brief

The goal of this clinical trial is to evaluate the efficacy and safety of metformin in treating patients with post chronic pancreatitis diabetes mellitus (PPDM-C). The main questions it aims to answer are: * What is the efficacy of metformin in glycemic control in patients with PPDM-C? * What is the incidence of adverse effects associated with metformin in patients with PPDM-C? Participants will be randomly assigned to receive either metformin or a placebo to see if metformin provides significant glycemic control and to assess the safety profile of the treatment.

Key facts

Study ID

NCT06937294

Run by

Changhai Hospital

People needed

58

Starts

2025-04-28

Expected to finish

2026-01-31

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-65 years, any sex.
• Patients diagnosed with chronic pancreatitis.
• Diagnose diabetes at least 3 months after chronic pancreatitis diagnosis.
• Never used any diabetes drug/glucose-lowering medication or had discontinued any glucose-lowering medications for at least 8 weeks prior to screening.
• HbA1c criteria: 7.5%\~9.0%.
• BMI >18.5.
• Provision of signed informed consent.

You may not qualify if…

• 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).
• Contraindications or history of intolerance or allergy to metformin.
• Fasting C-peptide <0.3 nmol/L.
• Acute episodes of chronic pancreatitis at enrollment or within 3 months prior to enrollment.
• History of congestive heart failure (NYHA class 3 or greater), unstable angina, or other severe cardiovascular diseases.
• History of cancer (except non-melanoma skin cancer) within 5 years prior to screening.
• History of partial or total pancreatectomy.
• History of or planning bariatric surgery.
• Previous organ transplantation.
• Treatment with oral or systemic glucocorticoids within 3 months prior to enrollment or plan to use during the study (inhaled steroids are permitted).
• History of hemolytic anemia, chronic transfusion requirements, or other conditions rendering HbA1c results unreliable.
• Other conditions requiring glucose-lowering medications, such as polycystic ovary syndrome.
• Fasting blood glucose >11.1 mmol/L during screening, requiring immediate treatment as judged by the physician.
• Sever psychiatric disorders or health conditions deemed unsuitable for clinical research participation.
• Pregnancy or plans for pregnancy during the course of the study.
• Any other condition considered by the investigator to be inappropriate for participation in the trial.

Where it is running

• Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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