Metformin in Post Chronic Pancreatitis Diabetes Mellitus

NCT06937294 | Recruiting Phase 4 DMC

• 1 other identifier: MOOD202501
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after the attainment of a stable dose

Secondary Outcomes (8)

• The proportion of patients with HbA1c below 6.5% at Week 12

  12 weeks after the attainment of a stable dose

• The proportion of patients with HbA1c below 7% at Week 12

  12 weeks after the attainment of a stable dose

• The proportion of patients with HbA1c below 7.5% at Week 12

  12 weeks after the attainment of a stable dose

• The incidence of adverse events

  12 weeks after the attainment of a stable dose

• Blood glucose profile characteristics

  12 weeks after the attainment of a stable dose

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Metformin DRUG

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.

Metformin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (9)

• 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: 33259158 RESULT

• 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: 28655595 RESULT

• 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: 35235728 RESULT

• 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: 32798493 RESULT

• 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: 27057870 RESULT

• 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: 31268977 RESULT

• 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: 35312752 RESULT

• 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: 34362812 RESULT

• 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.

  PMID: 31227582 RESULT

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Zhaoshen Li, M.D.

  Changhai Hospital

  STUDY CHAIR

• Lianghao Hu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianghao Hu, M.D.

CONTACT

+86-13817593520; lianghao-hu@smmu.edu.cn

Xiaoyu Zhou, M.D.

CONTACT

+86-17721292061; xyzhou0116@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized to the experimental group (metformin) or the control group (placebo).

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: April 28, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)