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

Phase 2CompletedNCT01607294

Esperion Therapeutics, Inc.60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hyperlipidemia Type 2 Diabetes

Interventions

ETC-1002DRUG

ETC-1002 Daily for 4 weeks

PlaceboDRUG

Placebo Daily for 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Miramar, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

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

Time frame: 4 weeks

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

Time frame: 4 weeks

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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