Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)

Phase 2

Recruiting

• Conditions: Pancretic Cancer; Diabete Mellitus
• Interventions: Drug: Metformin or insulin treatment

• Registration Number: NCT05306028
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-31
• Study Start: 2022-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Signed informed content obtained prior to treatment
• Age ≥ 18 years and ≤ 80 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have histologically confirmed pancreatic adenocarcinoma
• Fasting blood glucose ≥ 7.0 mmol/L（126 mg/dl）
• The expected survival after surgery ≥ 3 months

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Exclusion Criteria

• Active second primary malignancy or history of second primary malignancy
• Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
• Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc
• Total bilirubin (TBIL) > institutional upper limit of normal (ULN)
• Pregnant or nursing women
• Patients who are unwilling or unable to comply with study procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin or insulin treatment	Metformin or insulin treatment	-

Primary Outcome Measures

Name	Time	Method
Blood glucose control rate	1 week	Blood glucose control rate before and after anti-diabetic administration

Secondary Outcome Measures

Name	Time	Method
HbA1C control rate	1 week	HbA1C control rate before and after anti-diabetic administration

Trial Locations

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China