Clinical Trials

Clinical Trials

endo-trialsIn a Clinical Trial a new drug, treatment or procedure is tested in a group of volunteers. The most common drugs, diagnostic techniques and procedures in today's medical society, were at one time, revolutionary ideas that were tested, proven and improved by the four phases of the clinical trial system.

The heroes of this process are the volunteers. Volunteers, who are properly informed of any risks associated with trial participation, are not only helping to advance medical science but are also the earliest beneficiaries of the finest medical treatments in the world.

Please email ctu@louisville.edu or call (502) 852-1006 for more information.

Below are current clinical trials:

  • Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study

Sponsor
Merck Sharp & Dohme

Collaborator
Pfizer

Purpose
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study.

Study Drug
Ertugliflozin oral, once daily, up to 6.1 years. Other Name: MK-8835

Status
Active, NOT recruiting

More information at clinicaltrials.gov (NCT01986881)

 

  • A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

Sponsor
Sanofi

Purpose
Demonstrate clinical benefit of Toujeo in achieving individualized HEDIS HbA1c targets (<8% if age 65 years or with defined comorbidities (as listed in Appendix G) or otherwise <7%) at 6 months without documented symptomatic (BG 70mg/dl) hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive patients with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:
Compare Toujeo to other commercially available basal insulins at 6 and 12 months after initiating insulin therapy in a real world setting in terms of:

  • Patient persistence with assigned basal insulin therapy
  • Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia
  • Changes in HbA1c, fasting plasma glucose, body weight
  • Differences in patient- and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions DTSQs and DTSQc), Hypoglycemia Patient Questionnaire, and patient and provider reported Global Effectiveness Scale (GES)
  • Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Study Drug

  • INSULIN GLARGINE (U300) subcutaneous once daily on top of non-insulin antidiabetic agents. Other Name: Toujeo
  • INSULIN GLARGINE (U100) subcutaneous once or twice daily according to label on top of non-insulin antidiabetic agents. Other Name: Lantus
  • Insulin detemir subcutaneous once or twice daily according to label on top of non-insulin antidiabetic agents. Other name: Levemir

Status
Active, NOT recruiting

More information at clinicaltrials.gov (NCT02451137)