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

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia; Type 2 Diabetes

Treatments: Drug: ETC-1002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607294

1002-005

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

ETC-1002

Experimental group

Description:

ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day

Treatment:

Drug: ETC-1002

Placebo

Placebo Comparator group

Description:

Placebo daily 4 weeks

Treatment:

Drug: Placebo