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Metformin in Post Chronic Pancreatitis Diabetes Mellitus: a Double-blind, Randomized, Placebo-controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
⁃ 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%\
• 0%.
⁃ BMI \>18.5.
⁃ Provision of signed informed consent.
Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Lianghao Hu, M.D.
lianghao-hu@smmu.edu.cn
+86-13817593520
Backup
Xiaoyu Zhou, M.D.
xyzhou0116@163.com
+86-17721292061
Time Frame
Start Date:2025-04-28
Estimated Completion Date:2026-01-31
Participants
Target number of participants:58
Treatments
Experimental: Metformin
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.
Placebo_comparator: 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.