Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

— AGAC2  

Official title:

Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473147
• Other study ID #: CMRPG3A0911
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: July 28, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide
Exenatide 5 microgram bid sc.
• Normal saline
Normal saline 2 u bid sc.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amplitude of glycaemic excursions (MAGE)		During 6-day treatment course	No
Secondary	homeostasis model assessment(HOMA)		During 6-day treatment course	No