Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
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|ClinicalTrials.gov Identifier: NCT01269047|
Recruitment Status : Completed
First Posted : January 4, 2011
Results First Posted : February 8, 2018
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Pramlintide Drug: Exenatide Drug: Insulin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-prandial Hyperglycemia|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Pramlintide + Insulin Group
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
Other Name: Symlin
Experimental: Exenatide + Insulin Group
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
Active Comparator: Insulin monotherapy
This group will be on their regular insulin therapy.
Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
- Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus. [ Time Frame: 6 months ]We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus
- Difference in HbA1C Between the Treatment and the Control Groups [ Time Frame: 6 months ]
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): NCT01269047
|United States, New York|
|Albert Einstein College of Medicine West Campus Clinical Research Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Rubina A Heptulla, MD||Albert Einstein College of Medicine, Inc.|