Chronic PancreatitisPhase 4MOODNCT06937294
Metformin in Post Chronic Pancreatitis Diabetes Mellitus
A Phase 4 study testing Metformin in people with Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Lianghao Hu, M.D., +86-13817593520, lianghao-hu@smmu.edu.cn
Xiaoyu Zhou, M.D., +86-17721292061, xyzhou0116@163.com
About this study
Official title: Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial
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.
Read the detailed description
Chronic pancreatitis (CP) is an irreversible chronic fibro-inflammatory disease caused by multiple factors. Patients often present with recurrent upper abdominal pain, dyspepsia, steatorrhea, and other symptoms. Typical imaging findings of CP include pancreatic duct calcification, ductal dilation, and parenchymal atrophy. As pancreatic fibrosis progresses, islet cells may also be damaged, leading to abnormal glucose metabolism or even diabetes mellitus (DM). Approximately 25-80% of CP patients develop DM which has been called post chronic pancreatitis diabetes mellitus (PPDM-C), with the prevalence increasing with the duration of CP. PPDM-C has garnered significant attention in the academic community due to its unique clinical manifestations and complications. However, there is currently no well-defined management strategy for PPDM-C.
The management of PPDM-C requires balancing pancreatic endocrine and exocrine functions, and developing individualized treatment strategies. Compared with T2DM patients, PPDM-C patients face greater difficulty in achieving optimal glycemic control. Currently, there is no standardized management for PPDM-C, with treatment protocol largely relying on clinical experience. Metformin is the most frequently used medication for PPDM patients (64.5%), and is typically the initial treatment. In PPDM-C patients, previous metformin use is associated with a survival benefit over those who have never used any antidiabetic drugs. However, there is lake of clinical trails specifically addressing PPDM-C to elucidate the the efficacy in glycemic control and safety of metformin.
- Conditions
- Chronic Pancreatitis
- Being tested
- Metformin, Placebo
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Metformin | 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. Receives: Drug: Metformin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin (HbA1c)
The change in the value of glycosylated hemoglobin (HbA1c) collected at Week 12 (after the attainment of a stable does) relative to baseline.
Measured: 12 weeks after the attainment of a stable dose
Secondary outcomes (8)
The proportion of patients with HbA1c below 6.5% at Week 12
At the Week 12 after the attainment of a stable does, the proportions of patients with glycosylated hemoglobin (HbA1c) levels exceeding 6.5% are assessed.
Measured: 12 weeks after the attainment of a stable dose
The proportion of patients with HbA1c below 7% at Week 12
At the Week 12 after the attainment of a stable does, the proportions of patients with glycosylated hemoglobin (HbA1c) levels exceeding 7% are assessed.
Measured: 12 weeks after the attainment of a stable dose
The proportion of patients with HbA1c below 7.5% at Week 12
At the Week 12 after the attainment of a stable does, the proportions of patients with glycosylated hemoglobin (HbA1c) levels exceeding 7.5% are assessed.
Measured: 12 weeks after the attainment of a stable dose
The incidence of adverse events
Adverse events include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, acute pancreatitis and gastrointestinal symptoms (nausea, vomiting, diarrhea, etc.).
Measured: 12 weeks after the attainment of a stable dose
Blood glucose profile characteristics
Blood glucose profile from continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).
Measured: 12 weeks after the attainment of a stable dose
Exploratory objectives: pancreatic and gut hormones
Levels of specific pancreatic hormones (C-peptide, insulin, glucagon, etc.) and gut hormones (ghrelin, gastric inhibitory peptide, glucagon like peptide-1, etc.) measured in venous blood (unit: mmol/L or mg/dL).
Measured: Baseline
Exploratory objectives: pancreatic exocrine function
Pancreatic exocrine function is evaluated by fecal elastase-1 test.
Measured: 12 weeks after the attainment of a stable dose
Exploratory objectives: scores of quality of life
Quality of life scores for patients with chronic pancreatitis are obtained using SF-36 (36-Item Short Form Health Survey) which contains 8 dimensions scored from 0 to 100 (standardized converted scores). The higher score means better function.
Measured: 12 weeks after the attainment of a stable dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start28 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to the experimental group (metformin) or the control group (placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, M.D., Study chair, Changhai HospitalLianghao Hu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937294
- Sponsor's protocol ID
- MOOD202501
- Acronym
- MOOD
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho J, Petrov MS. Pancreatitis, Pancreatic Cancer, and Their Metabolic Sequelae: Projected Burden to 2050. Clin Transl Gastroenterol. 2020 Nov;11(11):e00251. doi: 10.14309/ctg.0000000000000251.
PubMed 33259158Petrov MS. Diabetes of the exocrine pancreas: American Diabetes Association-compliant lexicon. Pancreatology. 2017 Jul-Aug;17(4):523-526. doi: 10.1016/j.pan.2017.06.007. Epub 2017 Jun 19.
PubMed 28655595Vege SS, Chari ST. Chronic Pancreatitis. N Engl J Med. 2022 Mar 3;386(9):869-878. doi: 10.1056/NEJMcp1809396. No abstract available.
PubMed 35235728Beyer G, Habtezion A, Werner J, Lerch MM, Mayerle J. Chronic pancreatitis. Lancet. 2020 Aug 15;396(10249):499-512. doi: 10.1016/S0140-6736(20)31318-0.
PubMed 32798493Pan J, Xin L, Wang D, Liao Z, Lin JH, Li BR, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hu LH, Li ZS. Risk Factors for Diabetes Mellitus in Chronic Pancreatitis: A Cohort of 2,011 Patients. Medicine (Baltimore). 2016 Apr;95(14):e3251. doi: 10.1097/MD.0000000000003251.
PubMed 27057870Zhu X, Liu D, Wei Q, Lin H, Zhi M, Chen Y, Qi L, Waldron RT, Lugea A, Pandol SJ, Li L. New-Onset Diabetes Mellitus After Chronic Pancreatitis Diagnosis: A Systematic Review and Meta-analysis. Pancreas. 2019 Aug;48(7):868-875. doi: 10.1097/MPA.0000000000001359.
PubMed 31268977Olesen SS, Viggers R, Drewes AM, Vestergaard P, Jensen MH. Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality in Postpancreatitis Diabetes Mellitus Versus Type 2 Diabetes: A Nationwide Population-Based Cohort Study. Diabetes Care. 2022 Jun 2;45(6):1326-1334. doi: 10.2337/dc21-2531.
PubMed 35312752Viggers R, Jensen MH, Laursen HVB, Drewes AM, Vestergaard P, Olesen SS. Glucose-Lowering Therapy in Patients With Postpancreatitis Diabetes Mellitus: A Nationwide Population-Based Cohort Study. Diabetes Care. 2021 Sep;44(9):2045-2052. doi: 10.2337/dc21-0333. Epub 2021 Aug 6.
PubMed 34362812Cho J, Scragg R, Pandol SJ, Goodarzi MO, Petrov MS. Antidiabetic Medications and Mortality Risk in Individuals With Pancreatic Cancer-Related Diabetes and Postpancreatitis Diabetes: A Nationwide Cohort Study. Diabetes Care. 2019 Sep;42(9):1675-1683. doi: 10.2337/dc19-0145. Epub 2019 Jun 21.
PubMed 31227582
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06937294
- Acronym / sponsor ID
- MOOD / MOOD202501
- Conditions
- Chronic Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pancreatitis (CP) is an irreversible chronic fibro-inflammatory disease caused by multiple factors. Patients often present with recurrent upper abdominal pain, dyspepsia, steatorrhea, and other symptoms. Typical imaging findings of CP include pancreatic duct calcification, ductal dilation, and parenchymal atrophy. As pancreatic fibrosis progresses, islet cells may also be damaged, leading to abnormal glucose metabolism or even diabetes mellitus (DM). Approximately 25-80% of CP patients develop DM which has been called post chronic pancreatitis diabetes mellitus (PPDM-C), with the prevalence increasing with the duration of CP. PPDM-C has garnered significant attention in the academic community due to its unique clinical manifestations and complications. However, there is currently no well-defined management strategy for PPDM-C.
The management of PPDM-C requires balancing pancreatic endocrine and exocrine functions, and developing individualized treatment strategies. Compared with T2DM patients, PPDM-C patients face greater difficulty in achieving optimal glycemic control. Currently, there is no standardized management for PPDM-C, with treatment protocol largely relying on clinical experience. Metformin is the most frequently used medication for PPDM patients (64.5%), and is typically the initial treatment. In PPDM-C patients, previous metformin use is associated with a survival benefit over those who have never used any antidiabetic drugs. However, there is lake of clinical trails specifically addressing PPDM-C to elucidate the the efficacy in glycemic control and safety of metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to the experimental group (metformin) or the control group (placebo).
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants 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. | Drug | Metformin |
| PlaceboParticipants 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. | Drug | Placebo |
Primary outcome
Change from baseline in glycosylated hemoglobin (HbA1c)
Time frame: 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.
8 secondary outcomes
The proportion of patients with HbA1c below 6.5% at Week 12
Time frame: 12 weeks after the attainment of a stable dose
The proportion of patients with HbA1c below 7% at Week 12
Time frame: 12 weeks after the attainment of a stable dose
The proportion of patients with HbA1c below 7.5% at Week 12
Time frame: 12 weeks after the attainment of a stable dose
The incidence of adverse events
Time frame: 12 weeks after the attainment of a stable dose
Blood glucose profile characteristics
Time frame: 12 weeks after the attainment of a stable dose
Exploratory objectives: pancreatic and gut hormones
Time frame: Baseline
Exploratory objectives: pancreatic exocrine function
Time frame: 12 weeks after the attainment of a stable dose
Exploratory objectives: scores of quality of life
Time frame: 12 weeks after the attainment of a stable dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 33259158Cho J, Petrov MS. Pancreatitis, Pancreatic Cancer, and Their Metabolic Sequelae: Projected Burden to 2050. Clin Transl Gastroenterol. 2020 Nov;11(11):e00251. doi: 10.14309/ctg.0000000000000251.
- Results publication: PubMed 28655595Petrov MS. Diabetes of the exocrine pancreas: American Diabetes Association-compliant lexicon. Pancreatology. 2017 Jul-Aug;17(4):523-526. doi: 10.1016/j.pan.2017.06.007. Epub 2017 Jun 19.
- Results publication: PubMed 35235728Vege SS, Chari ST. Chronic Pancreatitis. N Engl J Med. 2022 Mar 3;386(9):869-878. doi: 10.1056/NEJMcp1809396. No abstract available.
- Results publication: PubMed 32798493Beyer G, Habtezion A, Werner J, Lerch MM, Mayerle J. Chronic pancreatitis. Lancet. 2020 Aug 15;396(10249):499-512. doi: 10.1016/S0140-6736(20)31318-0.
- Results publication: PubMed 27057870Pan J, Xin L, Wang D, Liao Z, Lin JH, Li BR, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hu LH, Li ZS. Risk Factors for Diabetes Mellitus in Chronic Pancreatitis: A Cohort of 2,011 Patients. Medicine (Baltimore). 2016 Apr;95(14):e3251. doi: 10.1097/MD.0000000000003251.
- Results publication: PubMed 31268977Zhu X, Liu D, Wei Q, Lin H, Zhi M, Chen Y, Qi L, Waldron RT, Lugea A, Pandol SJ, Li L. New-Onset Diabetes Mellitus After Chronic Pancreatitis Diagnosis: A Systematic Review and Meta-analysis. Pancreas. 2019 Aug;48(7):868-875. doi: 10.1097/MPA.0000000000001359.
- Results publication: PubMed 35312752Olesen SS, Viggers R, Drewes AM, Vestergaard P, Jensen MH. Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality in Postpancreatitis Diabetes Mellitus Versus Type 2 Diabetes: A Nationwide Population-Based Cohort Study. Diabetes Care. 2022 Jun 2;45(6):1326-1334. doi: 10.2337/dc21-2531.
- Results publication: PubMed 34362812Viggers R, Jensen MH, Laursen HVB, Drewes AM, Vestergaard P, Olesen SS. Glucose-Lowering Therapy in Patients With Postpancreatitis Diabetes Mellitus: A Nationwide Population-Based Cohort Study. Diabetes Care. 2021 Sep;44(9):2045-2052. doi: 10.2337/dc21-0333. Epub 2021 Aug 6.
- Results publication: PubMed 31227582Cho J, Scragg R, Pandol SJ, Goodarzi MO, Petrov MS. Antidiabetic Medications and Mortality Risk in Individuals With Pancreatic Cancer-Related Diabetes and Postpancreatitis Diabetes: A Nationwide Cohort Study. Diabetes Care. 2019 Sep;42(9):1675-1683. doi: 10.2337/dc19-0145. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoshen Li, M.D. study chair
Changhai Hospital
Lianghao Hu, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianghao Hu, M.D. (+86-13817593520, lianghao-hu@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycosylated hemoglobin (HbA1c) (time frame: 12 weeks after the attainment of a stable dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06937294, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.