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

NCT00782795 | Completed Phase 2 Results DMC

• 3 other identifiers: CP-PENQEX-1R21AA017271R21AA0172711R21AA017271-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pancreatitis; Insulin Resistance; Normal or Mildly Abnormal Stool Fat Levels

Keywords

Chronic pancreatitis; Insulin resistance

Outcome Measures

Primary Outcomes (4)

• Glucose Tolerance at 24 Weeks

  1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.

  24 weeks

• Glucose Tolerance at 48 Weeks

  1. Normal = normal plasma glucose and normal glucose tolerance (OGTT). 2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose \>110 mg/dl and \<126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) \>140 mg/dl and \<200 mg/dl. 3. Diabetes = fasting plasma glucose \>126 mg/dl 2-hour (OGTT) plasma glucose \>200 mg/dl.

  48 weeks

• Insulin Sensitivity Index for Glycemia at 24 Weeks

  Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.

  24 weeks

• Insulin Sensitivity Index for Glycemia at 48 Weeks.

  Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / (\[INSp x GLYp\] + 1). GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr glucose. INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 \& 2 hr insulin.

  48 weeks

Secondary Outcomes (10)

• Beta-cell Function

  24, 48 weeks

• Insulin Resistance at 24 and 48 Weeks

  24, 48 weeks

• Pancreas Ultrasound Appearance

  48 weeks

• Quality of Life

  24, 48 weeks

• Number and Percentage of Participants With Steatorrhea

  48 weeks

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Drug: Pioglitazone

sugar pill (placebo)

PLACEBO COMPARATOR

1 sugar pill (placebo) taken once daily for 48 weeks.

Drug: Placebo

Interventions

Pioglitazone DRUG

Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.

Also known as: Actos

Pioglitazone

Placebo DRUG

sugar pill (placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Insulin Resistance

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Matthew DiMagno
• Organization: University of Michigan

mdimagno@umich.edu

Study Officials

• Matthew DiMagno, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 11, 2018
• Results First Posted: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)