Back to resultsA Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Primary Purpose
Hyperlipidemia, Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ETC-1002
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of type 2 diabetes meeting all of the following:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ETC-1002
Placebo
Arm Description
ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Placebo daily 4 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT01607294
First Posted
April 26, 2012
Last Updated
March 26, 2019
Sponsor
Esperion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01607294
Brief Title
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Official Title
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Esperion Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ETC-1002
Arm Type
Experimental
Arm Description
ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily 4 weeks
Intervention Type
Drug
Intervention Name(s)
ETC-1002
Intervention Description
ETC-1002 Daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Daily for 4 weeks
Primary Outcome Measure Information:
Title
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
Description
evaluate the change in LDL-C from baseline to various time points
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin
Description
evaluate the change in glucose and insulin from baseline to various time points
Time Frame
4 weeks
Title
assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes
Description
evaluate the change in HOMA-IR from baseline to various time points
Time Frame
4 weeks
Title
assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters
Description
evaluate any changes in safety parameters during the course of the study.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 2 diabetes meeting all of the following:
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
Facility Information:
City
Miramar
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24385236
Citation
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.
Results Reference
derived
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A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
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