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

Diabete Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306028
• Other study ID #: PTCA199-2
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus

Intervention

Drug:
• Metformin or insulin treatment
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. For patients with history of diabetes Adjusting metformin or insulin dosage according to the monitor of fasting blood glucose.

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (4)

Bragg F, Holmes MV, Iona A, Guo Y, Du H, Chen Y, Bian Z, Yang L, Herrington W, Bennett D, Turnbull I, Liu Y, Feng S, Chen J, Clarke R, Collins R, Peto R, Li L, Chen Z; China Kadoorie Biobank Collaborative Group. Association Between Diabetes and Cause-Spec — View Citation

Pannala R, Basu A, Petersen GM, Chari ST. New-onset diabetes: a potential clue to the early diagnosis of pancreatic cancer. Lancet Oncol. 2009 Jan;10(1):88-95. doi: 10.1016/S1470-2045(08)70337-1. — View Citation

Sharma A, Kandlakunta H, Nagpal SJS, Feng Z, Hoos W, Petersen GM, Chari ST. Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes. Gastroenterology. 2018 Sep;155(3):730-739.e3. doi: 10.1053/j.gastro.2018.05.023. Epub 2018 Jun 11 — View Citation

Yuan C, Rubinson DA, Qian ZR, Wu C, Kraft P, Bao Y, Ogino S, Ng K, Clancy TE, Swanson RS, Gorman MJ, Brais LK, Li T, Stampfer MJ, Hu FB, Giovannucci EL, Kulke MH, Fuchs CS, Wolpin BM. Survival among patients with pancreatic cancer and long-standing or rec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	1 week
Other	Overall survival,OS	OS of subjects from recruiting to the time of death from any cause	At the end of Cycle 1 (each cycle is 28 days)
Primary	Blood glucose control rate	Blood glucose control rate before and after anti-diabetic administration	1 week
Secondary	HbA1C control rate	HbA1C control rate before and after anti-diabetic administration	1 week