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NCT Number: NCT05306028

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

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.

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Key information

Conditions

Pancretic Cancer Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • History of diabetes mellitus, or newly diagnosed diabetes mellitus according to the American Diabetes Association criteria
  • 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 including surgery, chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
  • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc
  • Pregnant or nursing women
  • Patients who are unwilling or unable to comply with study procedures

Treatment and study plan

Metformin or insulin treatment

Drug
  • 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.

Primary outcomes

  1. Blood glucose control rate

    Time frame: 1 week

    Blood glucose control rate before and after anti-diabetic administration

Secondary outcomes

  1. HbA1C control rate

    Time frame: 1 week

    HbA1C control rate before and after anti-diabetic administration

Other outcomes

  1. Change in serum Carbohydrate Antigen 19-9 (CA19-9) From Baseline to Day 8.

    Time frame: 1 week

    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.

  2. Overall survival，OS

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    OS of subjects from recruiting to the time of death from any cause

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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