Chronic PancreatitisPhase 2NCT00782795
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
A Phase 2 study testing Pioglitazone in people with Chronic Pancreatitis and Insulin Resistance, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Insulin Resistance, Normal or Mildly Abnormal Stool Fat Levels
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Insulin resistance or mild diabetes mellitus
- Symptoms of abdominal pain
- Xray test showing damage to the pancreas
- Normal or mildly abnormal stool fat levels
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Pioglitazone, Placebo
- Keywords
- Chronic pancreatitis, Insulin resistance
- Medical subject headings
- Pancreatitis, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Participants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. Receives: Drug: Pioglitazone |
| sugar pill (placebo) | Placebo comparator | 1 sugar pill (placebo) taken once daily for 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance at 24 Weeks
- Normal = normal plasma glucose and normal glucose tolerance (OGTT).
- 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.
- Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
Measured: 24 weeks
Glucose Tolerance at 48 Weeks
- Normal = normal plasma glucose and normal glucose tolerance (OGTT).
- 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.
- Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
Measured: 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.
Measured: 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.
Measured: 48 weeks
Secondary outcomes (10)
Beta-cell Function
Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Measured: 24, 48 weeks
Insulin Resistance at 24 and 48 Weeks
Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Measured: 24, 48 weeks
Pancreas Ultrasound Appearance
Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:
Parenchymal Features - Only Body and Tail
- Calcification (>3 hyperechoic foci >2 mm length \& width with shadowing)
- Lobularity (>3 well-circumscribed, >5mm structures)
- Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail
- Cyst (>2 mm diameter anechoic round or oval structure)
- Hyperechoic foci (>3 reflectors, >3 mm long \& wide, no shadowing) Ductal Features - Only Body and Tail
- Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)
- Irregular MPD contour (uneven and ectatic in its course)
- Hyperechoic MPD margin (hyperechoic in >50% of MPD)
- Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail
- MPD calculi (hyperechoic foci with shadowing contained within MPD)
Measured: 48 weeks
Quality of Life
The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.
Measured: 24, 48 weeks
Number and Percentage of Participants With Steatorrhea
Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours
Measured: 48 weeks
Pain
Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)
- What is your pain right now?
- What is your typical or average pain in the last 12 weeks?
- What is your pain level at its best in the last 12 weeks (how close to "0" does your pain get at its best)?
- What is your pain level at its worst in the last 12 weeks (how close to "0" does your pain get at its worst)?
Measured: 12, 24, 36, 48 and 60 weeks
Body Mass Index (BMI)
standard BMI defined as mass in kilograms divided by height in meters squared
Measured: 12, 24, 36, 48 and 60 weeks
Hospitalizations
Mean number of hospitalizations within the prior 12 weeks
Measured: 12, 24, 36, 48 and 60 weeks
Missed Work
Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)
Measured: 12, 24, 36, 48, 60 weeks
Insulin Sensitivity (%S)
Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;
Measured: 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Matthew DiMagno, MD, University of Michigan
- Investigators
- Matthew DiMagno, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782795
- Sponsor's protocol ID
- CP-PENQEX-1R21AA017271
- Other IDs
- R21AA017271, 1R21AA017271-01A1
- Status last verified
- Dec 2017
- First submitted
- 29 Oct 2008
- Last updated
- 11 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
- ClinicalTrials.gov ID
- NCT00782795
- Acronym / sponsor ID
- CP-PENQEX-1R21AA017271
- Keywords
- Chronic pancreatitis, Insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Takeda Pharmaceuticals North America, Inc.
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: Pioglitazone30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. |
| sugar pill (placebo) | Placebo comparator | Drug: Placebo1 sugar pill (placebo) taken once daily for 48 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Insulin resistance or mild diabetes mellitus
- Symptoms of abdominal pain
- Xray test showing damage to the pancreas
- Normal or mildly abnormal stool fat levels
Key exclusion criteria (26 listed)
- Mentally disabled patients
- Women who are planning pregnancy, pregnant or lactating/nursing
- Chronic pancreatitis is due to other specific conditions
- Surgical resection of the head of the pancreas
- Alcohol consumption within prior 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: ActosParticipants randomized to pioglitazone receive 30 mg taken once daily for 48 weeks. | Drug | Pioglitazone |
| Placebo | Drug | sugar pill (placebo) |
Primary outcome
Glucose Tolerance at 24 Weeks
Time frame: 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.
Glucose Tolerance at 48 Weeks
Time frame: 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.
Insulin Sensitivity Index for Glycemia at 24 Weeks
Time frame: 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.
Insulin Sensitivity Index for Glycemia at 48 Weeks.
Time frame: 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.
10 secondary outcomes
Beta-cell Function
Time frame: 24, 48 weeks
Insulin Resistance at 24 and 48 Weeks
Time frame: 24, 48 weeks
Pancreas Ultrasound Appearance
Time frame: 48 weeks
Quality of Life
Time frame: 24, 48 weeks
Number and Percentage of Participants With Steatorrhea
Time frame: 48 weeks
Pain
Time frame: 12, 24, 36, 48 and 60 weeks
Body Mass Index (BMI)
Time frame: 12, 24, 36, 48 and 60 weeks
Hospitalizations
Time frame: 12, 24, 36, 48 and 60 weeks
Missed Work
Time frame: 12, 24, 36, 48, 60 weeks
Insulin Sensitivity (%S)
Time frame: 24 and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew DiMagno, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone in people with Chronic Pancreatitis and Insulin Resistance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Tolerance at 24 Weeks (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.