Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients (AGAC2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01473147
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Exenatide Drug: Normal saline Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Active Comparator: GLP-1 Drug: Exenatide
Exenatide 5 microgram bid sc.
Other Name: Byetta

Placebo Comparator: Normal saline Drug: Normal saline
Normal saline 2 u bid sc.

Primary Outcome Measures :
  1. Mean amplitude of glycaemic excursions (MAGE) [ Time Frame: During 6-day treatment course ]

Secondary Outcome Measures :
  1. homeostasis model assessment(HOMA) [ Time Frame: During 6-day treatment course ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01473147

Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: CHIA-HUNG LIN, M.D. Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital Identifier: NCT01473147     History of Changes
Other Study ID Numbers: CMRPG3A0911
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: November 2011

Keywords provided by Chang Gung Memorial Hospital:
GLP-1 analogue
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists