Phase 2
N=64
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Diabetes Mellitus, Type II · Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT00501592 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Insulin Resistance and Glucose Homeostasis — .69; .24; -0.51; .73 mg/kg/min — p=0.040
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INT-747 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intercept Pharmaceuticals
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Resistance and Glucose Homeostasis |
.69; .24; -0.51; .73; .42; -0.61 | 0.040 sig |
| SECONDARY Hepatocellular Function |
-9; 9; 11; -3; 4; 4 | 0.0031 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00501592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.