Experimental Studies Heart Disease And Diabetes
Every experiment in the United States has to be registered with ClinicalTrials.gov. Visit the clinical trials website. Select Heart disease and Diabetes. Search these disease in clinical trials. Select a clinical trial that is currently going on with this disease.
a. 300 - 500 words, describe the clinical trial, inclusion, and exclusion criteria.
What phase is this trial?
Is it single or double blind?
Sample Solution
The clinical trial that is currently going on for both Heart Disease and Diabetes is called, “A Study to Evaluate the Safety and Efficacy of a Combination Oral Therapy (Alogliptin/Metformin HCl) Versus Alogliptin Monotherapy in Type 2 Diabetes”. This study is in Phase 3b. It is a randomized, double-blind, placebo-controlled trial being conducted at multiple sites in the United States with an adult population diagnosed with type 2 diabetes mellitus.
This clinical trial evaluates whether or not this combination therapy (alogliptin/metformin HCl) improves glycemic control compared to alogliptin monotherapy over a period of 24 weeks. The primary endpoint of this study will measure change from baseline in blood glucose levels after 24 weeks among participants treated with combination therapy versus those treated with alogliptin monotherapy.
Inclusion criteria for this clinical trial are: aged 18 years or older; clinically diagnosed type 2 diabetes mellitus; inadequate glycemic control as defined by A1C greater than 6%, but less than 9%; no history of any cardiovascular events within 12 months prior to enrollment into the study; agreed to adhere to all safety guidelines during the course of the trial. Exclusion criteria include: taking other oral antidiabetic medications; any evidence or suspicion of active allergic reactions related to treatments used during the course of this study; participation in another interventional research within 30 days prior to screening visit, etc.
This study is double blind meaning that neither patients nor investigators know which treatment patients receive until after completion of patient follow up visits.