Metformin in Post Chronic Pancreatitis Diabetes Mellitus
Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial
Changhai Hospital
58 participants
Apr 28, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria16
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants are administered metformin with an initial dose of 500 mg/day, which was incrementally increased by 500 mg/day each week until the maximum tolerated dose. The maximum dose of metformin is set at 2000 mg/day.
Participants are administered a placebo, starting with one tablet per day, followed by an incremental increase of one tablet per week. In the absence of adverse reactions, the dosage is escalated up to a maximum of four tablets per day.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06937294