ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00501592
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : January 27, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Brief Summary:

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-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Fatty Liver Drug: INT-747 Drug: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Study Start Date : July 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009


Arm Intervention/treatment
Active Comparator: 25 mg INT-747 Drug: INT-747
25 mg by mouth once daily, 50 mg by mouth once daily
Active Comparator: 50 mg INT-747 Drug: INT-747
25 mg by mouth once daily, 50 mg by mouth once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Insulin Resistance and Glucose Homeostasis [ Time Frame: baseline and 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).


Secondary Outcome Measures :
  1. Hepatocellular Function [ Time Frame: baseline and 6 weeks ]
    Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00501592


Locations
United States, California
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
UC San Diego VAMC
San Diego, California, United States, 92161
United States, Texas
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Commonwelath University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Intercept Pharmaceuticals
Investigators
Study Director: David A Shapiro, M.D. Intercept Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00501592     History of Changes
Other Study ID Numbers: 747-203
First Posted: July 16, 2007    Key Record Dates
Results First Posted: January 27, 2012
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by Intercept Pharmaceuticals:
Farnesoid X receptor agonist
Metabolic Disorder
Diabetes
NAFLD

Additional relevant MeSH terms:
Diabetes Mellitus
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents