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

March 26, 2019 updated by: Esperion Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
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
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esperion Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (ESTIMATE)

May 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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