What benefits does CGM have over fingersticks for people with type 2 diabetes? What effect on the heart does Victoza have?
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results – A Long-Term Evaluation (LEADER)
ClinicalTrials.gov Identifier: NCT01179048
Over the past few years, there has been growing excitement for GLP-1 agonists (Byetta and Victoza are the two currently available in the US), as they lower blood glucose while causing less hypoglycemia and less weight gain (they even promote weight loss) than other currently available diabetes drugs. On top of those effects, evidence is mounting to suggest that GLP-1 agonists may also confer benefits to the cardiovascular system. LEADER, the cardiovascular outcomes trial for Victoza (Novo Nordisk’s liraglutide), aims to characterize the long-term effects of Victoza on cardiovascular outcomes in individuals with type 2 diabetes. Study participants will be randomized to receive Victoza or placebo once daily and will be followed for up to five years for the first occurrence of cardiovascular death, heart attack, or stroke. To be eligible to participate, individuals must have type 2 diabetes, be at least 50 years of age, and have cardiovascular disease, cerebrovascular disease (e.g. stroke), peripheral arterial disease, chronic renal failure, or chronic heart failure. Individuals are also eligible if they have type 2 diabetes, are at least 60 years of age, and have specific risk factors for vascular disease. Finally, individuals must have an A1c of 7.0% or above and must not have used a GLP-1 agonist, pramlintide, DPP-4 inhibitor, or prandial insulin three months prior to screening. The study will take place in over 30 states (as well as international locations) – for a complete list of study locations, please click here. If you are interested in participating, please call the Novo Nordisk Clinical Trial Call Center at (866) 867-7178. --VW
Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (REACT3)
ClinicalTrials.gov Identifier: NCT01237301
Continuous glucose monitoring (CGM) is widely accepted by insurers as a supplement to fingersticks for individuals with type 1 diabetes. However, for those with type 2 diabetes, the use of CGM is still not covered by many insurance policies because few studies have examined the benefits of this technology in this population. To that effect, this 16-week study at the International Diabetes Center (in Minneapolis) aims to characterize the effectiveness of self-monitoring of blood glucose (SMBG) and CGM for decision making in diabetes self-management as well as any incremental benefits CGM has beyond SMBG for individuals with type 2 diabetes. Participants assigned to self monitor their blood glucose (SMBG) will measure blood glucose four to seven times per day using fingersticks and an AccuChek Aviva blood glucose meter, while participants assigned to continuous glucose monitoring (CGM) will have their blood glucose measured continuously using the DexCom SEVEN PLUS device. Outcomes that will be measured include changes in A1c, total glucose exposure, glucose variability, glucose stability (change from hour to hour), and the incidence of hypoglycemia. To be eligible to participate, you must have type 2 diabetes, be between the ages of 18 and 75, and have an A1c of 7.0% or greater. In addition, you must not have been treated with a thiazolidinedione (Avandia, Actos), been administered prednisone or cortisone medications in the previous 30 days, be pregnant, or plan to be pregnant during the study. If you’re interested in participating, please contact Sarah Borgman at (952) 993-0827 or [email protected], or Anne Gilsdorf at (952) 993-3267 or [email protected]. --VW
