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

NCT ID: NCT01260246

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-04-30

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.

Conditions

Type 2 Diabetes; Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sitagliptin

sitagliptin 100mg/daily for 6 months

Group Type: EXPERIMENTAL

sitagliptin

Intervention Type: DRUG

pill, 100mg/daily for 6 months

placebo

placebo match for 6 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo match for 6 months

Interventions

sitagliptin

pill, 100mg/daily for 6 months

Intervention Type: DRUG

placebo

placebo match for 6 months

Intervention Type: DRUG

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Tisha Joy

Assistant Professor, Division of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tisha Joy, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care, UWO

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

Other Identifiers

17389

Identifier Type: REGISTRY

Identifier Source: secondary_id

R-10-533

Identifier Type: -

Identifier Source: org_study_id