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

NCT ID: NCT01473147

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLP-1

Group Type: ACTIVE_COMPARATOR

Exenatide

Intervention Type: DRUG

Exenatide 5 microgram bid sc.

Normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline 2 u bid sc.

Interventions

Exenatide

Exenatide 5 microgram bid sc.

Intervention Type: DRUG

Normal saline

Normal saline 2 u bid sc.

Intervention Type: DRUG

Other Intervention Names

Byetta

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CHIA-HUNG LIN, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CMRPG3A0911

Identifier Type: -

Identifier Source: org_study_id