Sitagliptin for the Treatment of Non-alcoholic Steatohepa... | NCT01260246

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

NCT01260246

Sponsor

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

Status

Terminated

Last Update Posted

Mar 14, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes
Nonalcoholic Steatohepatitis

Interventions

sitagliptin
placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
17389	Registry Identifier	Office of Research Ethics, UWO

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Dec 13, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2017

Last Update Posted Date

Mar 14, 2017Actual

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
sitagliptin	Experimental	sitagliptin 100mg/daily for 6 months	Drug: sitagliptin
placebo	Placebo Comparator	placebo match for 6 months	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
sitagliptin	Drug	pill, 100mg/daily for 6 months	sitagliptin
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.		3 years

Secondary Outcomes

Measure	Description	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.		3 years
In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.

Other Outcomes

Not provided

Eligibility Module

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003924	Diabetes Mellitus, Type 2
D065626	Non-alcoholic Fatty Liver Disease

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds