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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
PSI Foundation inc
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01260246
First received: December 13, 2010
Last updated: June 29, 2011
Last verified: June 2011

December 13, 2010
June 29, 2011
December 2010
November 2013   (final data collection date for primary outcome measure)
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01260246 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Nonalcoholic Steatohepatitis
  • Drug: sitagliptin
    pill, 100mg/daily for 6 months
  • Drug: placebo
    placebo match for 6 months
  • Experimental: sitagliptin
    sitagliptin 100mg/daily for 6 months
    Intervention: Drug: sitagliptin
  • Placebo Comparator: placebo
    placebo match for 6 months
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2013
November 2013   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
Contact: Tisha Joy, MD 519-646-6296
Canada
 
NCT01260246
R-10-533, 17389
No
Dr. Tisha Joy/ Principal Investigator, St. Joseph's Health Care, Department of Medicine, UWO
Lawson Health Research Institute
PSI Foundation inc
Principal Investigator: Tisha Joy, MD St. Joseph's Health Care, UWO
Lawson Health Research Institute
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP