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Study to Evaluate the Safety and Efficacy of PAZ320 When Added to Oral Agents or Insulin in Patients With Type 2 Diabetes Mellitus
This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.
In this study, the investigators seek to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans. Continuous glucose monitors (CGM) are minimally invasive devices that measure glucose levels in interstitial fluid. A small wire is inserted subcutaneously which transmits the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder. In usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify trends or look back over time (ie over night). In our study, the patient will be blinded to the data so as not to confound results, as it has been noted in another study that patient's blood sugar control was better when they were able to see CGM results and modified their diet. CGM's have been shown to have clinical accuracies of 95.5-98.9% and have been used in clinical trials and found to be safe. Having the patient do a finger-stick glucose intermittently during the time they are wearing the CGM improves accuracy.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Dartmouth-Hitchcock Medical Center
Jefferson, New Hampshire, United States
Start Date
March 1, 2011
Primary Completion Date
August 1, 2011
Completion Date
August 1, 2011
Last Updated
February 13, 2014
24
ACTUAL participants
PAZ320
DRUG
Lead Sponsor
Boston Therapeutics
NCT06579404
NCT06311019
NCT04585191
Data Source & Attribution
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