Overview

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

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
Summary
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Esperion Therapeutics
Esperion Therapeutics, Inc.
Treatments:
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
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