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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01607294
First received: April 26, 2012
Last updated: February 10, 2014
Last verified: February 2014

April 26, 2012
February 10, 2014
April 2012
October 2012   (final data collection date for primary outcome measure)
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
evaluate the change in LDL-C from baseline to various time points
Same as current
Complete list of historical versions of study NCT01607294 on ClinicalTrials.gov Archive Site
  • assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    evaluate any changes in safety parameters during the course of the study.
Same as current
Not Provided
Not Provided
 
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Type 2 Diabetes
Drug: ETC-1002 or placebo
Daily for 4 weeks
  • Experimental: ETC-1002
    Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
    Intervention: Drug: ETC-1002 or placebo
  • Placebo Comparator: Placebo
    Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day
Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and Safety of ETC-1002, a Novel Investigational Low-Density Lipoprotein-Cholesterol-Lowering Therapy for the Treatment of Patients With Hypercholesterolemia and Type 2 Diabetes Mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01607294
1002-005
No
Esperion Therapeutics
Esperion Therapeutics
Not Provided
Not Provided
Esperion Therapeutics
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP