Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01137695|
Recruitment Status : Unknown
Verified October 2011 by Cheryl Rosenfeld, DO, North Jersey Endocrine Consultants, LLC.
Recruitment status was: Active, not recruiting
First Posted : June 4, 2010
Last Update Posted : October 14, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Pramlintide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||April 2012|
Active Comparator: Symlin Naive, Usual Dose
Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
120 mcg SQ three times daily for 6 months.
Experimental: Symlin Naive, Dose Escalation
Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
360 mcg SQ three times daily for 6 months
Active Comparator: Symlin treated, Usual Dose
pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.
120 mcg SQ three times daily for 6 months
Experimental: Symlin Treated, Dose Escalation
pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
360 mcg SQ three times daily for 6 months
- Glucose control [ Time Frame: 6 months ]A1c Fasting plasma glucose Post-prandial glucose Glycomark
- Weight loss [ Time Frame: 6 months ]Weight, BMI, Waist circumference.
- amylin level [ Time Frame: initial ]does initial blood amylin level correlate with need for higher dose pramlintide?
- glucagon level [ Time Frame: 6 months ]Does change in glucagon level correlate with glycemic response.
- adverse effects [ Time Frame: 6 months ]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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137695
|United States, New Jersey|
|North Jersey Endocrine Consultants|
|Denville, New Jersey, United States, 07834|
|United States, New York|
|University Physicians Group|
|Staten Island, New York, United States, 10301|
|United States, Pennsylvania|
|St. Mary Medical Center|
|Langhorne, Pennsylvania, United States, 19047|
|Principal Investigator:||Cheryl Rosenfeld, DO||North Jersey Endocrine Consultants|
|Principal Investigator:||Jeffrey Rothman, MD||University Physicians Group Research|
|Principal Investigator:||Alan Schorr, DO||St. Mary Medical Center|