| Trial ID: | L3797 |
| Source ID: | NCT00501592
|
| Associated Drug: |
Int-747
|
| Title: |
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00501592/results
|
| Conditions: |
Diabetes Mellitus, Type II|Fatty Liver
|
| Interventions: |
DRUG: INT-747|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: Hepatocellular Function, Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function, baseline and 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Intercept Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-07
|
| Completion Date: |
2009-04
|
| Results First Posted: |
2012-01-27
|
| Last Update Posted: |
2012-04-20
|
| Locations: |
Profil Institute for Clinical Research, Inc., Chula Vista, California, 91911, United States|UC San Diego VAMC, San Diego, California, 92161, United States|Diabetes & Glandular Disease Research Associates, Inc., San Antonio, Texas, 78229, United States|Virginia Commonwelath University, Richmond, Virginia, 23298, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00501592
|
