TrialWatch
Januvia/Janumet and you, the type 2
The goal of this study is to test the safety and efficacy of Januvia and Janumet - both oral antidiabetes drugs often touted for their ease of use and relatively mild side effects (less hypoglycemia and weight gain). Janumet is simply a combination of Januvia and metformin - the former works to increase insulin secretion while the latter works to decrease glucose production by the liver. Check out Issue 4's New Now Next for more information. The study will compare the effects of these drugs on A1c levels to Actos, a thiozoledinedione (Issue 6 learning curve) over 40 weeks. Enrollment started in November, and they are looking to recruit just over 450 people. Studies will be conducted in Nebraska and Pennsylvania. Please contact this toll free number for more information: 1-888-577-8839.
RT-CGM in type 1 management
This study will look be performed in two phases:
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The first phase entails a six month trial comparing two blood glucose monitoring technologies:
- real-time continuous glucose monitoring (RT-CGM)
- home glucose monitoring
- The second phase involves the RT-CGM group for an additional six-month observational study to determine whether any beneficial effects from the first phase of the study could be sustained with longer-term use and less contact with the physician. The group that was using home glucose monitoring will initiate RT-CGM with less intensive contact than provided during phase 1 for the original RT-CGM group.
The CGM devices under investigation are the Abbott Navigator, the DexCom STS and the Paradigm or Guardian REAL-time.
Requirements for the study stipulate that participants must over 8 years with an A1c less than or equal to 10 percent. This study is recruiting in California, Colorado, Connecticut, Florida, Georgia, Iowa, Massachussets and Washington.
Please contact Katrina Ruedy at 813-975-8690 (kruedy@jaeb.org) or Judy Jackson at 813-975-8690 (jjackson@jaeb.org) for more information.
Getting to the bottom of the incretin debate
This study seeks to understand the defects of insulin secretion that lead to abnormal breakdown of glucose in diabetes patients. It will focus on the incretin effect, which you can read more about in issue 5 What We're Reading. In short, an incretin is a gut hormone that promotes insulin release from the beta cells of the pancreas after eating. They also reduce the rate at which digested food is absorbed into the blood and prevent the body from releasing glucagon - a hormone released to increase blood glucose levels. This study is looking to conclusively determine the effect of two incretins, GLP-1 and GIP, on post-meal insulin secretion by comparing their effects both in diabetic patients and in non-diabetics. Requirements for the diabetic patients include: A1c between 6.5 and 9.5 percent, treatment with metformin, sulfonylurea or a combination of the two, and a BMI between 28 and 40. Participants without diabetes must be between 30 and 65 without a history of the disease. The study will be located in Ohio and will start recruiting early next year. Please contact Dr. D'Alessio at 513-558-6899 or email him at David.D'Alessio@uc.edu for more information.