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This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 | Experimental | ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day |
|
| Placebo | Placebo Comparator | Placebo daily 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | ETC-1002 Daily for 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miramar | Florida | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24385236 | Derived | Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
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| Drug |
Placebo Daily for 4 weeks |
|
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 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |