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

Phase 2

Completed

• Conditions: Hyperlipidemia; Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: ETC-1002

• Registration Number: NCT01607294
• Lead Sponsor: Esperion Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-30
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Disposition First Submitted: 2015-08-13
• Disposition First Submitted QC: 2015-08-27
• Disposition First Posted: 2015-09-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo daily 4 weeks
ETC-1002	ETC-1002	ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day

Primary Outcome Measures

Name	Time	Method
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes	4 weeks	evaluate the change in LDL-C from baseline to various time points

Secondary Outcome Measures

Name	Time	Method
assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin	4 weeks	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	4 weeks	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	4 weeks	evaluate any changes in safety parameters during the course of the study.