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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607294
• Other study ID #: 1002-005
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: March 2019
• Source: Esperion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Type 2 Diabetes

Intervention

Drug:
• ETC-1002
ETC-1002 Daily for 4 weeks
• Placebo
Placebo Daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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.	4 weeks