trial watch

A Study Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog)

ClinicalTrials.gov Identifier: NCT01686620

BIOD-123 is Biodel’s main ultra-rapid-acting insulin in development. Biodel previously submitted the ultra-rapid-acting insulin Linjeta for FDA approval in 2010, but it was rejected due to efficacy and tolerability concerns. The past two years have seen Biodel go back to the drawing board (see new now next in diaTribe #45 for an update on Biodel’s recent activity), and BIOD-123 has emerged as its most promising ultra-rapid-acting insulin candidate. This newly announced phase 2 study will compare mealtime use of BIOD-123 to Eli Lilly’s rapid-acting Humalog (insulin lispro). Both groups will use Lantus (Sanofi’s insulin glargine) for basal insulin. The study will track the reduction in A1c after 18 weeks, differences in hypoglycemia, changes in daily glucose measurements, and insulin doses. Participants must be at least 18 years old, have had type 1 diabetes for at least a year, and have a BMI between 18 and 35 kg/m². Importantly, participants must be willing to use only Sanofi’s Lantus (insulin glargine) as their basal insulin throughout the course of the study, and they must discontinue use of a pump if they are currently on one. The study will recruit 130 participants at 31 study locations in 16 states (CA, FL, GA, ID, KS, KY, MD, MI, MO, MT, NV, NY, OH, OR, TX, WA). For more information on this study, contact the study center nearest to you – phone numbers and emails for each site are available here. We have high hopes for BIOD-123 given the tremendous need for a faster-acting insulin, especially for the artificial pancreas. –AW

A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes (AWARD-6)

ClinicalTrials.gov Identifier: NCT01624259

Three GLP-1 agonists are currently FDA approved for the treatment of type 2 diabetes: Novo Nordisk’s once-daily Victoza (liraglutide) and Amylin/BMS/AZ’s twice-daily Byetta (exenatide) and once-weekly Bydureon (exenatide once-weekly). The approval of Bydureon at the beginning of this year was especially exciting, as it combined the considerable benefits of the GLP-1 agonist class – significant A1c reduction, weight loss, and little to no hypoglycemia – with a single once-weekly injection. Eli Lilly is hoping to offer its own once-weekly GLP-1 agonist, dulaglutide, and the company is now recruiting for the latest in a series of phase 3 trials. This study will compare once-weekly dulaglutide to once-daily Victoza on a variety of measures over 26 weeks: A1c, change in body weight, change in blood glucose, change in blood pressure, etc. Both groups will also continue to take metformin while in the study. Participants must have type 2 diabetes, be 18 years or older, have an A1c between 7.0% and 10.0%, and have a BMI below 45 kg/m². A complete list of the inclusion and fairly extensive exclusion criteria can be found here. The study is looking to recruit 592 participants at 60 locations in 12 states (AZ, CA, CO, FL, KS, KY, LA, MI, NV, OH, TN, TX) and Puerto Rico, the Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Slovakia, and Spain. For more information on the study, call 1-877-285-4559 or 1-317-615-4559 between 9AM and 5PM Eastern, Monday through Friday. –AW