Using metformin to treat diabetes after chronic pancreatitis

Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial

This study is testing if metformin can help people with diabetes that developed after chronic pancreatitis manage their blood sugar better and stay safe from side effects.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06937294 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of metformin in patients diagnosed with post chronic pancreatitis diabetes mellitus (PPDM-C). Participants will be randomly assigned to receive either metformin or a placebo to assess its impact on glycemic control and the incidence of adverse effects. The study aims to address the lack of standardized management strategies for PPDM-C, which is a condition that arises in a significant number of chronic pancreatitis patients. By focusing on this specific patient population, the trial seeks to provide insights into effective treatment options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of chronic pancreatitis and diabetes that developed at least three months after their pancreatitis diagnosis.

Not a fit: Patients with type 1 diabetes or secondary diabetes not caused by chronic pancreatitis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve glycemic control in patients suffering from diabetes related to chronic pancreatitis.

How similar studies have performed: While there is limited research specifically on metformin for PPDM-C, metformin has shown efficacy in other diabetes populations, suggesting potential for success in this novel application.

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/glucose-lowering medication or had discontinued any glucose-lowering 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.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Principal investigator: Lianghao Hu, M.D. — Changhai Hospital
• Study coordinator: Lianghao Hu, M.D.

Conditions Chronic Pancreatitis