| Trial ID: | L1891 |
| Source ID: | NCT01607294
|
| Associated Drug: |
Etc-1002
|
| Title: |
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperlipidemia|Type 2 Diabetes
|
| Interventions: |
DRUG: ETC-1002|DRUG: Placebo
|
| Outcome Measures: |
Primary: assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes, evaluate the change in LDL-C from baseline to various time points, 4 weeks | Secondary: assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin, evaluate the change in glucose and insulin from baseline to various time points, 4 weeks|assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes, evaluate the change in HOMA-IR from baseline to various time points, 4 weeks|assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters, evaluate any changes in safety parameters during the course of the study., 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Esperion Therapeutics, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-04
|
| Completion Date: |
2012-10
|
| Results First Posted: |
|
| Last Update Posted: |
2019-03-29
|
| Locations: |
Miramar, Florida, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01607294
|
