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NCT Number: NCT01607294

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

This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.

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Key information

Conditions

Hyperlipidemia Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miramar, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETC-1002

Drug

ETC-1002 Daily for 4 weeks

Placebo

Drug

Placebo Daily for 4 weeks

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 30, 2012
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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