Study of INT-747 in Patients With Diabetes and Presumed NAFLD - Full Text View

Sponsored by:	Intercept Pharmaceuticals
Information provided by:	Intercept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00501592

Purpose

The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

The safety and tolerability of multiple doses of INT 747;
The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis;
Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and;
Trough concentrations of INT-747 and its metabolites, glyco 6-ECDCA and tauro 6-ECDCA.

Condition	Intervention	Phase
Diabetes Mellitus, Type II Fatty Liver	Drug: INT-747	Phase II

MedlinePlus related topics: Diabetes Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease

Further study details as provided by Intercept Pharmaceuticals:

Primary Outcome Measures:

The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	July 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 25 mg	Drug: INT-747 25 mg PO QD, 50 mg PO QD, Placebo PO QD
2: Experimental 50 mg	Drug: INT-747 25 mg PO QD, 50 mg PO QD, Placebo PO QD
3: Placebo Comparator Placebo	Drug: INT-747 25 mg PO QD, 50 mg PO QD, Placebo PO QD

Detailed Description:

This is a multi-center, double-blind, randomized, placebo-controlled, multiple-dose, parallel-group study. Three (3) cohorts of 12 patients each will receive either placebo, 25 mg INT-747, or 50 mg INT-747 by mouth daily for 6 weeks.

The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43). Other endpoints will be evaluated by monitoring adverse experiences; vital signs; clinical laboratory values; plasma drug and metabolite concentrations; and general health and well-being.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:
Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) or
Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or
2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).
Presumed NAFLD, defined by one of the following criteria:
Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males
Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males
Enlarged liver (demonstrated by ultrasound or other imaging technique)
Diagnostic histological findings shown on prior biopsy (in the last 5 years).

Exclusion Criteria:

Bilirubin >2 × ULN
ALT >155 U/L for females and >185 U/L for males.
AST >155 U/L for females and >200 U/L for males.
Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501592

Locations

United States, California
UC San Diego VAMC	Recruiting
San Diego, California, United States, 92161
Contact: Paivi M Burke 858-642-3997 paivi.burke@va.gov
Principal Investigator: Sunder Mudaliar, MD
United States, Texas
Diabetes & Glandular Disease Research Associates, Inc.	Recruiting
San Antonio, Texas, United States, 78229
Contact: Mark Kipnes, M.D. 210-615-5555
Principal Investigator: Mark Kipnes, M.D.
United States, Virginia
Virginia Commonwelath University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Sherry Boyett 804-828-5434 slboyett@vcu.edu
Principal Investigator: Arun J Sunyal, MD

Sponsors and Collaborators

Intercept Pharmaceuticals

Investigators

Study Director:

David A Shapiro, M.D.

Intercept Pharmaceuticals

More Information

Responsible Party:	Intercept Pharmaceuticals ( David A. Shapiro, MD - Chief Medical Officer, Intercept Pharmaceuticals )
Study ID Numbers:	747-203
Study First Received:	July 13, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00501592
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intercept Pharmaceuticals:

Farnesoid X receptor agonist
Metabolic Disorder
Diabetes
NAFLD

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Fatty Liver
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009