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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
120 mcg SQ three times daily for 6 months.
360 mcg SQ three times daily for 6 months
120 mcg SQ three times daily for 6 months
360 mcg SQ three times daily for 6 months
North Jersey Endocrine Consultants
Denville, New Jersey, United States
University Physicians Group
Staten Island, New York, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
Glucose control
A1c Fasting plasma glucose Post-prandial glucose Glycomark
Time frame: 6 months
Weight loss
Weight, BMI, Waist circumference.
Time frame: 6 months
amylin level
does initial blood amylin level correlate with need for higher dose pramlintide?
Time frame: initial
glucagon level
Does change in glucagon level correlate with glycemic response.
Time frame: 6 months
adverse effects
Whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg TID (as compared to the clinical practice study) - GI: nausea 30% and Hypoglycemia: medically assisted 0.7% or patient ascertained 0.7%.
Time frame: 6 months
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