A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
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
1 other identifier
interventional
60
1 country
1
Brief Summary
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 29, 2019
March 1, 2019
6 months
April 26, 2012
March 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin
4 weeks
assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes
4 weeks
assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters
4 weeks
Study Arms (2)
ETC-1002
EXPERIMENTALETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Placebo
PLACEBO COMPARATORPlacebo daily 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Miramar, Florida, United States
Related Publications (1)
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.
PMID: 24385236DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2012
First Posted
May 30, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 29, 2019
Record last verified: 2019-03