Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.

The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.

The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar), malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is considered an irreversible condition because the mechanisms responsible for chronic pancreatitis are poorly understood and no therapy is proven. However, recent studies provide important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus might improve or reverse features of chronic pancreatitis, including elevated sugar or diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.

Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.

Inclusion Criteria:

• Insulin resistance or mild diabetes mellitus
• Symptoms of abdominal pain
• Xray test showing damage to the pancreas
• Normal or mildly abnormal stool fat levels

Exclusion Criteria:

• Mentally disabled patients

• Women who are planning pregnancy, pregnant or lactating/nursing

• Chronic pancreatitis is due to other specific conditions

  • Autosomal dominant pancreatitis
  • Classic cystic fibrosis with lung involvement
  • Autoimmune pancreatitis
  • Pancreatic cancer
  • Biliary obstruction (non-pancreatic cause)
  • Abdominal trauma
  • Hypercalcemia
  • Hypertriglyceridemia

• Surgical resection of the head of the pancreas

• Alcohol consumption within prior 2 months

• Specific medical conditions

  • Gastric surgery
  • Celiac sprue
  • Crohns disease
  • Heart failure
  • Kidney failure
  • Cirrhosis or liver disease
  • Osteoporosis
  • Blood clotting disorder
  • Visual problems
  • Low albumin
  • Low BMI

• Specific medications *Diabetes drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.