Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type II, Fatty Liver
In brief
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.
Key facts
- Study ID
- NCT00501592
- Run by
- Intercept Pharmaceuticals
- People needed
- 64
- Starts
- 2007-07-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2012-04-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- 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).
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11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.
Where it is running
- Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
- UC San Diego VAMC — San Diego, California, United States
- Diabetes & Glandular Disease Research Associates, Inc. — San Antonio, Texas, United States
- Virginia Commonwelath University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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