Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients (AGAC2)
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|ClinicalTrials.gov Identifier: NCT01473147|
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : July 30, 2013
Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control. Nevertheless, the clinical effects and mechanisms are still unclear when additional supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly controlled Type 2 diabetes patients. This study is designed to understand the complementary pharmacological effects of GLP-1 analogue on intensive CSII treatment.
Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6 days CSII intensive treatment. Following the normalization of blood glucose at first 3 days, the patients are randomly assigned with combined therapy with exenatide injection or saline for another 3 days. The clinical assessments of insulin requirement, insulin secretion, insulin resistance glycemic excursions and cytokines will perform immediately during or after the study.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Exenatide Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Active Comparator: GLP-1||
Exenatide 5 microgram bid sc.
Other Name: Byetta
|Placebo Comparator: Normal saline||
Drug: Normal saline
Normal saline 2 u bid sc.
- Mean amplitude of glycaemic excursions (MAGE) [ Time Frame: During 6-day treatment course ]
- homeostasis model assessment(HOMA) [ Time Frame: During 6-day treatment course ]
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): NCT01473147
|Chang Gung Memorial Hospital|
|Taoyuan, Taiwan, 333|
|Principal Investigator:||CHIA-HUNG LIN, M.D.||Chang Gung Memorial Hospital|