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Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260246
Recruitment Status : Terminated (Slow recruitment)
First Posted : December 15, 2010
Last Update Posted : March 14, 2017
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Tisha Joy, Lawson Health Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Nonalcoholic Steatohepatitis Drug: sitagliptin Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes.
Study Start Date : December 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: sitagliptin
sitagliptin 100mg/daily for 6 months
Drug: sitagliptin
pill, 100mg/daily for 6 months

Placebo Comparator: placebo
placebo match for 6 months
Drug: placebo
placebo match for 6 months

Primary Outcome Measures :
  1. To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress. [ Time Frame: 3 years ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. Alcohol consumption (< 10g/day in women and <20g/day in men)
    2. Cause of liver disease other than NAFLD (negative investigations for: viral hepatitis, iron overload, a-1 antitrypsin, ceruloplasmin, autoimmune disease)
    3. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260246

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Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
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Principal Investigator: Tisha Joy, MD St. Joseph's Health Care, UWO

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Responsible Party: Tisha Joy, Assistant Professor, Division of Endocrinology, Lawson Health Research Institute Identifier: NCT01260246     History of Changes
Other Study ID Numbers: R-10-533
17389 ( Registry Identifier: Office of Research Ethics, UWO )
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action