A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
NCT ID: NCT01607294
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2012-04-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ETC-1002
ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
ETC-1002
ETC-1002 Daily for 4 weeks
Placebo
Placebo daily 4 weeks
Placebo
Placebo Daily for 4 weeks
Interventions
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ETC-1002
ETC-1002 Daily for 4 weeks
Placebo
Placebo Daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Minimum 6 month history of diabetes prior to screening visit;
* Fasting C-peptide ≥ 0.8 ng/mL at screening visit;
* HbA1C at screening visit 7-10%;
* Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements.
* BMI at screening visit from 25-35 kg/m2;
* LDL-C at screening ≥ 100 mg/dL
18 Years
70 Years
ALL
No
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Miramar, Florida, United States
Countries
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References
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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.
Other Identifiers
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1002-005
Identifier Type: -
Identifier Source: org_study_id
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