NCT07272109

Active Anti-diabetic Treatment Plus Chemotherapy for Pancreatic Cancer Related Diabetes

Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of anti-diabetic treatment on improving the overall survival for metastatic pancreatic cancer patients complicated by diabetes receiving gemcitabine and nab-paclitaxel chemotherapy.

Detailed description

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 anti-diabetic treatment in type 3c diabetes.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel	120 mg per square meter of body-surface area on days 1, 8, and 15 every 4 weeks
DRUG	Gemcitabine (1000 mg/m2)	(1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
OTHER	Anti-Diabetics	Metformin, insulin or other anti-diabetic treatments
OTHER	Active treatment and monitoring	Attend follow-ups at designated endocrinology clinics, with proactive inquiry about hypoglycemic measures and medication implementation.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-12-09
• Last updated: 2025-12-15

Locations

1 site across 1 country: China