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Clinical trial

A Study in Subjects With Type 2 Diabetes Mellitus With Hypercholesterolemia/Mixed Dyslipidemia

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Last updated:16th May 2016
Identifier: NCT02739984

Brief Summary:
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in subjects with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Detailed Description:
This study will enroll adult subjects (greater than or equal to 18 years of age) with type 2 diabetes mellitus and elevated LDL-C or non-HDL-C levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study. Subjects must have hemoglobin A1c (HbA1c) < 10%, must have been receiving pharmacologic treatment for diabetes mellitus for greater than or equal to 6 months prior to screening, with stable diabetes therapy prior to randomization to investigational product (IP) and not expected to change throughout the duration of study participation.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia
Actual Study Start Date: May 17, 2016
Actual Primary Completion Date: September 5, 2017
Actual Study Completion Date: September 5, 2017

- Experimental:
Arm 1 - Evolocumab (QM)
- Placebo Comparator: Arm 2 - Placebo (QM)

Category Value
Date last updated at source 2017-09-12
Study type(s) Interventional
Expected enrolment 424
Study start date 2016-05-17
Estimated primary completion date 2017-09-05

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