Type 2 Diabetes Mellitus Clinical Trial
Official title:
Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus
The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who
do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily
with expected glucose control require higher than FDA approved dosage.
The primary objective of the study is to determine whether higher doses of pramlintide
(Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA
approved dose of 120 mcg three times daily.
The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more
efficacious in causing weight loss and reduction in waist circumference than standard dose
pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with
need for higher dose therapy,and to determine whether or not the rate of common adverse
effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times
daily.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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