- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260246
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes
March 13, 2017 updated by: Tisha Joy, Lawson Health Research Institute
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes.
This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results.
The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 4L6
- St. Joseph's Health Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Known DM2 (receiving lifestyle management and/or metformin and/or sulfonylurea
- Stable therapy for DM2 for the past 3 months
- All other medications and doses stable for past 3 months
- HbA1c 8.9% or lower (can be done in past 30 days)
Known NASH based on the accepted American Gastroenterological Association Criteria:
- Alcohol consumption (< 10g/day in women and <20g/day in men)
- Cause of liver disease other than NAFLD (negative investigations for: viral hepatitis, iron overload, a-1 antitrypsin, ceruloplasmin, autoimmune disease)
- Liver histology demonstrating macrovesicular fatty change of hepatocytes, with evidence of steatohepatitis, manifested by the presence of Mallory Bodies, ballooning degeneration, lobular neutrophilic inflammation and perisinusoidal fibrosis. (If liver biopsy done within 2 years prior to screening for this trial, that biopsy will be reviewed to ensure it meets criteria for diagnosis).
Exclusion Criteria:
- Any contraindication for undergoing MRI
- Child class B or C cirrhosis
- Participation in another clinical trial
- Use of thiazoledinedione (rosiglitazone or pioglitazone) in past 6 months
- Current use of plavix
- Previous exposure to sitagliptin
- Prior history of pancreatitis
- History of anaphylaxis to another Canadian-marketed DPP-IV inhibitor (saxagliptin)
- Creatine clearance <30 ml/min
- Anaemia (haemoglobin < 110 mg/dL)
- Platelet count < 50 000 cells/mm3
- Known heart or kidney failure
- Comorbid condition that decreases natural life span (e.g. known cancer)
- Pregnant or breastfeeding or wishing to become pregnant in the next 6 months
- Current or past treatment with medications that can induce steatohepatitis (e.g. glucocorticoids, methotrexate, amiodarone etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sitagliptin
sitagliptin 100mg/daily for 6 months
|
pill, 100mg/daily for 6 months
|
Placebo Comparator: placebo
placebo match for 6 months
|
placebo match for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In individuals with NASH and DM2: To document the impact of sitagliptin therapy on adipocytokines, inflammatory markers, non-traditional cardiovascular risk factors, adipose distribution, and dyslipidemia.
Time Frame: 3 years
|
3 years
|
In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.
Time Frame: 3 years
|
3 years
|
In individuals with NASH and DM2: To determine the correlation between changes in histology with changes in hepatic fat demonstrated by MRI and changes in fibrosis by Fibroscan.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tisha Joy, MD, St. Joseph's Health Care, UWO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
December 13, 2010
First Submitted That Met QC Criteria
December 14, 2010
First Posted (Estimate)
December 15, 2010
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Liver Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Sitagliptin Phosphate
Other Study ID Numbers
- R-10-533
- 17389 (Registry Identifier: Office of Research Ethics, UWO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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