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Recruiting Phase 4

Metformin in Post Chronic Pancreatitis Diabetes Mellitus

NCT06937294 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2025-04-28
Last updated
2025-05-21

Condition(s) studied

Chronic Pancreatitis

Investigational drug(s) / intervention(s)

Metformin →Placebo

Metformin: 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.

Placebo: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in glycosylated hemoglobin (HbA1c) — 12 weeks after the attainment of a stable dose
    The change in the value of glycosylated hemoglobin (HbA1c) collected at Week 12 (after the attainment of a stable does) relative to baseline.

Trial sites (1)

FacilityCityRegionStatus
Changhai Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937294 on ClinicalTrials.gov ↗ ← All trials in China