Recruiting

MOODMetformin for Post Chronic Pancreatitis Diabetes Mellitus

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What is being tested

Metformin

+ Placebo

Drug
Who is being recruted

Chronic Disease+5

+ Digestive System Diseases

+ Pancreatic Diseases

From 18 to 65 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorChanghai Hospital
Study ContactLianghao Hu, M.D.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 28, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on individuals with a condition called post chronic pancreatitis diabetes mellitus (PPDM-C), which can occur in people who have chronic pancreatitis. Chronic pancreatitis is a long-lasting inflammation of the pancreas, often leading to diabetes due to damage in the part of the pancreas that regulates blood sugar. People with PPDM-C often have difficulty controlling their blood sugar levels. This study investigates the use of a common diabetes medication, Metformin, to see how effective and safe it is for managing blood sugar in those with PPDM-C, as there is currently no established treatment specifically for this condition. Participants in this study will be randomly assigned to receive either Metformin or a placebo, which is a substance with no active medication, to compare the effects. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication, to ensure unbiased results. The primary focus is to assess how well Metformin controls blood sugar levels in PPDM-C patients and to evaluate any associated risks or benefits. This research aims to provide clearer guidelines for treating PPDM-C, potentially improving the quality of life for those affected by this challenging condition.

Official TitleMetformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial
NCT06937294
Principal SponsorChanghai Hospital
Study ContactLianghao Hu, M.D.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseDigestive System DiseasesPancreatic DiseasesPancreatitisPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesPancreatitis, Chronic

Criteria

7 inclusion criteria required to participate
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.
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16 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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. After 2 weeks of administration, participants will undergo safety assessments, including complete blood count, urinalysis, liver function tests, and renal function tests. After attainment to a stable dose of metformin, participants will undergo follow-up assessments at 4 weeks, 8 weeks, and 12 weeks. The final evaluation of outcome measures will be completed at the 12-week follow-up.

Group II

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. After 2 weeks of administration, participants will undergo safety assessments, including complete blood count, urinalysis, liver function tests, and renal function tests. After attainment to a stable dose, participants will undergo follow-up assessments at 4 weeks, 8 weeks, and 12 weeks. The final evaluation of outcome measures will be completed at the 12-week follow-up.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Changhai Hospital

Shanghai, ChinaOpen Changhai Hospital in Google Maps
Recruiting
One Study Center
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