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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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 1, 2010
Primary Completion Date
January 1, 2012
Completion Date
April 1, 2012
Last Updated
October 14, 2011
40
ESTIMATED participants
Pramlintide
DRUG
Pramlintide
DRUG
Pramlintide
DRUG
Pramlintide
DRUG
Lead Sponsor
Cheryl Rosenfeld, DO
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861