A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects with Type 2 Diabetes
ClinicalTrials.gov Identifier: NCT01464437
A class of type 2 diabetes medications in development called glucokinase activators (GKAs) aim to 1) increase the release of insulin only when levels of glucose are high and 2) reduce the production of glucose in the liver. While there is certainly potential in this class, previous studies suggest hypoglycemia could be a possible concern with GKAs. This phase 2 study will assess the effectiveness and safety of Amgen’s GKA candidate AMG 151 when used with metformin. The four-week study will give participants either AMG 151 at different doses or a placebo (inactive pill), then chart changes in glucose at day 28. Those interested in participating in this study should be between the ages of 18 and 65, have an A1c between 7.5% and 10.0%, and have been on only metformin for at least three months prior to beginning the study. For a full list of inclusion and exclusion criteria, please click here. The study is recruiting at 55 locations in 20 states (AL, AZ, AR, CA, FL, GA, ID, IN, LA, MD, MO, MT, NV, NY, NC, ND, OH, OK, TX, VA) and Puerto Rico. For more information, please contact the Amgen Call Center at 866-572-6436. –AW
Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
ClinicalTrials.gov Identifier: NCT01667185
Dexcom is beginning an observational study on the effectiveness of its next-generation continuous glucose monitor (CGM), the Dexcom G4 (see new now next in diaTribe #43 for more on this device), in children with type 1 diabetes. As we noted in conference pearls in diaTribe #44, compared to the current Seven Plus, the Dexcom G4 was found to be approximately 20% more accurate, especially in hypoglycemia, a significant worry for children. This study will collect one week’s worth of CGM data from children wearing the G4. Study participants must have type 1 diabetes and be between the ages of 2 and 17. Dexcom is looking to enroll 145 participants at five locations: Stanford University in Stanford, CA; the Barbara Davis Center in Aurora, CO; the Rocky Mountain Diabetes and Osteoporosis Center in Idaho Falls, ID; the University of Iowa Children’s Hospital in Iowa City, IA; and the Joslin Diabetes Center in Boston, MA. For contact information for each specific site, as well as a complete list of inclusion and exclusion criteria, please see the study’s page here.
The study is slated to complete by the end of 2012, at roughly the same time Dexcom is expected to receive FDA approval of the G4 for adult use. Dexcom’s current Seven Plus is not FDA approved for use in pediatrics (though off-label use certainly occurs and many patients’ insurance does pay for pediatric use even though it is not officially approved).Medtronic offers the only FDA-approved CGM for this age group. We hope that the G4 will be approved for use in these younger populations soon, which would help expand the use of CGM and we believe would be positive for patients overall. Ultimately, we believe 24/7 CGM use will represent the standard of care for testing glucose for anyone taking insulin and that intermittent CGM use will come into play for type 2 patients not on insulin. –AW/AB