Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
640
Trial Sponsor
Clinical Trial Start Date
2007
0Primary Completion Date
2009
0Study Completion Date
2009
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 20
Participating Facility
Official Name
An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease0
Last Updated
April 20, 2012
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Investigator0
Participant0
Other attributes
Intervention Treatment
INT-7470
Placebo0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
