Novel therapy for Type 2 patients

Novel Diabetes Treatment for Type 2 Diabetes: Study Subjects Needed

This is an opportunity for individuals w/ type 2 diabetes, 18 or older, who have suboptimal glucose control defined as HbA1c between 7-10% despite ongoing current treatment w/ diet, exercise, metformin 1500+ mg/day alone or with Actos 30+ mg/day. Any other active, ongoing treatments for diabetes would preclude study entry. Half the subjects qualifying are randomized to receive a novel combination product consisting of a new basal insulin, Degludec AND liraglutide (marketed now as Victoza) given already premixed, together as a single injection using a pen delivery device. One-quarter of subjects are randomized to receive Degludec alone and one-quarter to receive liraglutide alone. Both Degludec and liraglutide are also given as a single daily injection using a pen delivery device. All study treatment is added on to pre-study treatment and the study treatment is titrated to fasting target fingerstick glucose goal of 70-90 mg/dl. Every study subject is expected to experience improved glucose control as there is no placebo in this study. The primary study endpoint is HbA1c change. Secondary study endpoints include changes in fasting and postprandial fingerstick glucose, hypoglycemia & weight change. This is currently a six month study; however study extension to 12 mos for those intersested may be possible. All study subjects will be compensated ($) for their involvement. Six subjects are now enrolled at our site and doing well. We can enroll another nine subjects w/ qualifying HbA1c values between 7-10%, but enrollment may soon be restricted to individuals w/ higher HbA1c values, ie, 8.5-10%. Study enrollment is likely to continue until November 1, 2011.

If you think you may qualify & be interested in this opportunity, please call 489-4704 and ask for Dr Gerety or email Dr Gerety at ggerety@theendocrinegroup.com to inquire further.