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

Primary Purpose

Diabetes Mellitus, Type II, Fatty Liver

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

INT-747

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type II focused on measuring Farnesoid X receptor agonist, Metabolic Disorder, Diabetes, NAFLD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.

Sites / Locations

Profil Institute for Clinical Research, Inc.
UC San Diego VAMC
Diabetes & Glandular Disease Research Associates, Inc.
Virginia Commonwelath University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

25 mg INT-747

50 mg INT-747

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin Resistance and Glucose Homeostasis

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

Hepatocellular Function

Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function

Full Information

NCT ID

NCT00501592

First Posted

July 13, 2007

Last Updated

April 17, 2012

Sponsor

Intercept Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00501592

Brief Title

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

Official Title

An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intercept Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type II, Fatty Liver

Keywords

Farnesoid X receptor agonist, Metabolic Disorder, Diabetes, NAFLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

25 mg INT-747

Arm Type

Active Comparator

Arm Title

50 mg INT-747

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

INT-747

Intervention Description

25 mg by mouth once daily, 50 mg by mouth once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Insulin Resistance and Glucose Homeostasis

Description

Time Frame

baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Hepatocellular Function

Description

Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function

Time Frame

baseline and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A Shapiro, M.D.

Organizational Affiliation

Intercept Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institute for Clinical Research, Inc.

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

UC San Diego VAMC

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

Diabetes & Glandular Disease Research Associates, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Virginia Commonwelath University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23727264

Citation

Mudaliar S, Henry RR, Sanyal AJ, Morrow L, Marschall HU, Kipnes M, Adorini L, Sciacca CI, Clopton P, Castelloe E, Dillon P, Pruzanski M, Shapiro D. Efficacy and safety of the farnesoid X receptor agonist obeticholic acid in patients with type 2 diabetes and nonalcoholic fatty liver disease. Gastroenterology. 2013 Sep;145(3):574-82.e1. doi: 10.1053/j.gastro.2013.05.042. Epub 2013 May 30.

Results Reference

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

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