Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 1:00 AM
Study NCT ID:
NCT06937294
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin in Post Chronic Pancreatitis Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study is a double-blind trail. Participants, investigators, care providers and outcomes assessors are blinded to the group allocations. Investigators and care providers provide guidance on drug use and lifestyle. Outcomes assessors are responsible for the follow-up of the patients. A study coordinator, who is not blinded to the group allocations, is appointed to oversee the coordination of the study and the maintenance of the blinding procedures. The study coordinator do not be allowed to communicate with others (participants, investigators, care providers and outcomes assessors) regarding the group allocations and clinical conditions of the participants. In the event of a serious adverse event, the blinding could be broken by contacting the study coordinator for safety considerations, and the reasons for unblinding were documented in detail.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to the experimental group (metformin) or the control group (placebo).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in glycosylated hemoglobin (HbA1c)', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': 'The change in the value of glycosylated hemoglobin (HbA1c) collected at Week 12 (after the attainment of a stable does) relative to baseline.'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients with HbA1c below 6.5% at Week 12', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': '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.'}, {'measure': 'The proportion of patients with HbA1c below 7% at Week 12', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': 'At the Week 12 after the attainment of a stable does, the proportions of patients with glycosylated hemoglobin (HbA1c) levels exceeding 7% are assessed.'}, {'measure': 'The proportion of patients with HbA1c below 7.5% at Week 12', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': '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.'}, {'measure': 'The incidence of adverse events', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': 'Adverse events include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, acute pancreatitis and gastrointestinal symptoms (nausea, vomiting, diarrhea, etc.).'}, {'measure': 'Blood glucose profile characteristics', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': 'Blood glucose profile from continuous glucose monitoring system (CGMS) (unit: mmol/L or mg/dL).'}, {'measure': 'Exploratory objectives: pancreatic and gut hormones', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Exploratory objectives: pancreatic exocrine function', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': 'Pancreatic exocrine function is evaluated by fecal elastase-1 test.'}, {'measure': 'Exploratory objectives: scores of quality of life', 'timeFrame': '12 weeks after the attainment of a stable dose', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '33259158', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28655595', 'type': 'RESULT', 'citation': 'Petrov 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.'}, {'pmid': '35235728', 'type': 'RESULT', 'citation': 'Vege SS, Chari ST. Chronic Pancreatitis. N Engl J Med. 2022 Mar 3;386(9):869-878. doi: 10.1056/NEJMcp1809396. No abstract available.'}, {'pmid': '32798493', 'type': 'RESULT', 'citation': 'Beyer 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.'}, {'pmid': '27057870', 'type': 'RESULT', 'citation': 'Pan 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.'}, {'pmid': '31268977', 'type': 'RESULT', 'citation': 'Zhu 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.'}, {'pmid': '35312752', 'type': 'RESULT', 'citation': 'Olesen 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.'}, {'pmid': '34362812', 'type': 'RESULT', 'citation': 'Viggers 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.'}, {'pmid': '31227582', 'type': 'RESULT', 'citation': 'Cho 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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* What is the efficacy of metformin in glycemic control in patients with PPDM-C?\n* What is the incidence of adverse effects associated with metformin in patients with PPDM-C?\n\nParticipants 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-65 years, any sex.\n2. Patients diagnosed with chronic pancreatitis.\n3. Diagnose diabetes at least 3 months after chronic pancreatitis diagnosis.\n4. Never used any diabetes drug/glucose-lowering medication or had discontinued any glucose-lowering medications for at least 8 weeks prior to screening.\n5. HbA1c criteria: 7.5%\\~9.0%.\n6. BMI \\>18.5.\n7. Provision of signed informed consent.\n\nExclusion Criteria:\n\n1. 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).\n2. Contraindications or history of intolerance or allergy to metformin.\n3. Fasting C-peptide \\<0.3 nmol/L.\n4. Acute episodes of chronic pancreatitis at enrollment or within 3 months prior to enrollment.\n5. History of congestive heart failure (NYHA class 3 or greater), unstable angina, or other severe cardiovascular diseases.\n6. History of cancer (except non-melanoma skin cancer) within 5 years prior to screening.\n7. History of partial or total pancreatectomy.\n8. History of or planning bariatric surgery.\n9. Previous organ transplantation.\n10. Treatment with oral or systemic glucocorticoids within 3 months prior to enrollment or plan to use during the study (inhaled steroids are permitted).\n11. History of hemolytic anemia, chronic transfusion requirements, or other conditions rendering HbA1c results unreliable.\n12. Other conditions requiring glucose-lowering medications, such as polycystic ovary syndrome.\n13. Fasting blood glucose \\>11.1 mmol/L during screening, requiring immediate treatment as judged by the physician.\n14. Sever psychiatric disorders or health conditions deemed unsuitable for clinical research participation.\n15. Pregnancy or plans for pregnancy during the course of the study.\n16. Any other condition considered by the investigator to be inappropriate for participation in the trial.'}, 'identificationModule': {'nctId': 'NCT06937294', 'acronym': 'MOOD', 'briefTitle': 'Metformin in Post Chronic Pancreatitis Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'MOOD202501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': '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.', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lianghao Hu, M.D.', 'role': 'CONTACT', 'email': 'lianghao-hu@smmu.edu.cn', 'phone': '+86-13817593520'}, {'name': 'Xiaoyu Zhou, M.D.', 'role': 'CONTACT', 'email': 'xyzhou0116@163.com', 'phone': '+86-17721292061'}, {'name': 'Lianghao Hu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zhaoshen Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Lianghao Hu, M.D.', 'role': 'CONTACT', 'email': 'lianghao-hu@smmu.edu.cn', 'phone': '+86-13817593520'}, {'name': 'Xiaoyu Zhou, M.D.', 'role': 'CONTACT', 'email': 'xyzhou0116@163.com', 'phone': '+86-17721292061'}], 'overallOfficials': [{'name': 'Zhaoshen Li, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Changhai Hospital'}, {'name': 'Lianghao Hu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}