NCT00501592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 27, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.6 years

First QC Date

July 13, 2007

Results QC Date

June 7, 2011

Last Update Submit

April 17, 2012

Conditions

Diabetes Mellitus, Type IIFatty Liver

Keywords

Farnesoid X receptor agonistMetabolic DisorderDiabetesNAFLD

Outcome Measures

Primary Outcomes (1)

  • 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).

    baseline and 6 weeks

Secondary Outcomes (1)

  • Hepatocellular Function

    baseline and 6 weeks

Study Arms (3)

25 mg INT-747

ACTIVE COMPARATOR
Drug: INT-747

50 mg INT-747

ACTIVE COMPARATOR
Drug: INT-747

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

INT-747DRUG

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

25 mg INT-74750 mg INT-747
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

UC San Diego VAMC

San Diego, California, 92161, United States

Location

Diabetes & Glandular Disease Research Associates, Inc.

San Antonio, Texas, 78229, United States

Location

Virginia Commonwelath University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 23727264DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Fatty LiverMetabolic DiseasesDiabetes MellitusNon-alcoholic Fatty Liver Disease

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Cathi Sciacca, Sr. Director, Clinical Operations
Organization
Intercept Pharmaceuticals, Inc.
csciacca@interceptpharma.com
858-652-6800

Study Officials

  • David A Shapiro, M.D.

    Intercept Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

April 1, 2009

Last Updated

April 20, 2012

Results First Posted

January 27, 2012

Record last verified: 2012-04

Locations

US(4)