A Phase 2 interventional study of Metformin or insulin treatment in Pancretic Cancer and Diabete Mellitus, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.
Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Fudan University is the lead sponsor of 1,271 studies on the registry; 624 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Metformin or insulin treatment
1. For patients with new-onset diabetes Fasting blood glucose 7-10 mmol/L, metformin 2 g/day, BID, PO; Fasting blood glucose 10-14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 12 U before breakfast, 8 U; Fasting blood glucose \> 14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 16 U before breakfast, 10 U; Adjusting insulin dosage according to the monitor of fasting blood glucose. 2. For patients with history of diabetes Adjusting metformin or insulin dosage according to the monitor of fasting blood glucose.
Blood glucose control rate
Blood glucose control rate before and after anti-diabetic administration
Time frame: 1 week
HbA1C control rate
HbA1C control rate before and after anti-diabetic administration
Time frame: 1 week
Change in serum Carbohydrate Antigen 19-9 (CA19-9) From Baseline to Day 8.
Change of tumor biomarkers before and after anti-diabetic administration.Patients will collect CA19-9 values on the day of enrollment and on day 8.
Time frame: 1 week
Overall survival，OS
OS of subjects from recruiting to the time of death from any cause
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Plan to share: Undecided
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fudan University