Type 2 Diabetes Mellitus Clinical Trial
Official title:
Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients
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.
In the poorly controlled type 2 DM, insulin therapy is the treatment of choice to make sugar on target. Actually, however, the general control rate is not good and partially due to the complex etiology in type 2 DM. GLP-1 deficiency is the mostly emphasized in modern practice. In order to study the effect of GLP-1 analogue in insulinized type 2 DM patients, investigators have to optimize the insulin therapy in the first priority. Continuous subcutaneous insulin infusion (CSII) or insulin pump is a viable choice for patients with type 1 or type 2 DM who want close-to-physiologic insulin treatment. By means of the insulin pump therapy, standardized sugar control profile in type 2 DM patients could be achieved in a short time. Investigators can further evaluate the clinical response under GLP-1 analogue or not. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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