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A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607294
First Posted: May 30, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esperion Therapeutics
  Purpose
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.

Condition Intervention Phase
Hyperlipidemia Type 2 Diabetes Drug: ETC-1002 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes [ Time Frame: 4 weeks ]
    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 [ Time Frame: 4 weeks ]
    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 [ Time Frame: 4 weeks ]
    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 [ Time Frame: 4 weeks ]
    evaluate any changes in safety parameters during the course of the study.


Enrollment: 60
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002
ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Drug: ETC-1002
ETC-1002 Daily for 4 weeks
Placebo Comparator: Placebo
Placebo daily 4 weeks
Drug: Placebo
Placebo Daily for 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607294


Locations
United States, Florida
Miramar, Florida, United States
Sponsors and Collaborators
Esperion Therapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT01607294     History of Changes
Other Study ID Numbers: 1002-005
First Submitted: April 26, 2012
First Posted: May 30, 2012
Last Update Posted: September 11, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders