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:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01607294
First received: April 26, 2012
Last updated: February 10, 2014
Last verified: February 2014
  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 or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Drug: ETC-1002 or placebo
Daily for 4 weeks
Placebo Comparator: Placebo
Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607294

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

No publications provided by Esperion Therapeutics

Additional 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
Study First Received: April 26, 2012
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014