NCT06937294 Metformin in Post Chronic Pancreatitis Diabetes Mellitus
| NCT ID | NCT06937294 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Changhai Hospital |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 58 participants in total. It began in 2025-04-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zhaoshen Li, M.D.
STUDY CHAIR
Changhai Hospital
Frequently Asked Questions
Who can join the NCT06937294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06937294 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06937294 currently recruiting?
Yes, NCT06937294 is actively recruiting participants. Contact the research team at lianghao-hu@smmu.edu.cn for enrollment information.
Where is the NCT06937294 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06937294 clinical trial?
NCT06937294 is sponsored by Changhai Hospital. The principal investigator is Zhaoshen Li, M.D. at Changhai Hospital. The trial plans to enroll 58 participants.