trial watch January 31, 2012
REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)
ClinicalTrials.gov Identifier: NCT01483560
Metformin, a commonly used drug to treat type 2 diabetes, lowers blood glucose levels by increasing the body’s sensitivity to insulin, decreasing the body’s own production of glucose, and reducing the body’s absorption of glucose following meals. Outside of type 2 diabetes, early research has also examined the effects of metformin in type 1 diabetes. Results from these initial studies have suggested that metformin may also benefit people with type 1 diabetes by lowering their insulin dose requirements, improving their blood glucose control, reducing their weight, and improving their cardiovascular health. To further our understanding of the potential cardiovascular health and glucose control benefits provided by metformin, JDRF is helping to fund a much larger and longer trial (called REMOVAL) that will examine the effects of metformin in people with type 1 diabetes at increased risk for cardiovascular disease. The trial is three years in duration and expects to enroll approximately 500 participants. Once enrolled, participants will be randomly assigned to receive metformin or placebo (inactive pill). The trial will assess the effects of metformin on several measures of cardiovascular health (such as plaque build-up in arteries and “bad” [LDL] cholesterol levels [LDL]), as well as its effects on A1c, weight, and insulin dose requirements. To be eligible, participants must be diagnosed with type 1 diabetes, be at least 40 years of age, have an A1c between 7.0% and 10.0%, and have at least three of ten listed cardiovascular disease risk factors (e.g., strong family history of cardiovascular disease and blood pressure of 140/90 mmHg or higher). Additionally, participants must not have heart failure or had an acute coronary syndrome in the past three months. For a complete list of inclusion and exclusion criteria, please click here. The study is currently enrolling, and will be conducted at a total of 16 centers in Australia, Canada, Denmark, the Netherlands, and the UK. If you are eligible and interested in participating, please contact John Petrie (Glasgow, UK) at john.petrie@glasgow.ac.uk. –BK
Feasibility Study Assessing the Ability of an Insulin Pump-Controlling Algorithm to Minimize Hypoglycemia and Hyperglycemia in Patients with Type 1 Diabetes in a Clinical Research Setting
ClinicalTrials.gov Identifier: NCT01401751
The path to a fully automated system for glucose monitoring and insulin delivery (an artificial pancreas or “closed-loop” system – see Learning Curve in this issue) will likely occur in small steps, with technological advances at each stage. One of the final steps would involve precise control of blood glucose levels around a specific target value. But on the way toward achieving that goal, researchers must first demonstrate the ability of a system to maintain glucose levels within a wider range. This Animas-sponsored study will test the feasibility of an early-stage artificial pancreas product. Specifically, the study will test a hypoglycemia-hyperglycemia minimizer system while participants are under close medical supervision for 24 hours. The trial’s investigators will be looking at how well the system delivers insulin in response to glucose changes, how well it minimizes hypoglycemia, and whether it causes any adverse effects. The trial will take place at the Sansum Diabetes Research Institute in California and is currently recruiting participants between the ages of 21 and 65 who have had type 1 diabetes for at least a year and who have been using an insulin pump for at least the past six months. Individuals who are pregnant, and those who experienced diabetic ketoacidosis or severe hypoglycemia in the past six months, are ineligible to participate. If you are eligible and interested in participating, you can contact Dr. Henry Anhalt at 484 356-1850 or hanhalt@its.jnj.com or Jay Hobeika at 610-804-5758 or jhobei@its.jnj.com. –LR