Clinical trial NCT01473147: Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients
Official title: Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: GLP-1 analogue
CSII
insulin
type 2 diabetes mellitus
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 20 years old
* DM diagnosed \> 2 years
* HbA1c level of 8% to 12%
* Receiving insulin premixed insulin twice daily and total insulin daily dose \> 0.6 u/kg/day

Exclusion Criteria:

* Severe comorbidity, including CHF, CVA, liver cirrhosis, COPD, Cushing's syndrome etc.
* Psychologic problems, including anxiety
* Incorporation, including personal and familial factors

Primary outcomes:
measure: Mean amplitude of glycaemic excursions (MAGE)
timeFrame: During 6-day treatment course
Secondary outcomes:
measure: homeostasis model assessment(HOMA)
timeFrame: During 6-day treatment course
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: CHIA-HUNG LIN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: