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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01473147
First received: November 14, 2011
Last updated: July 28, 2013
Last verified: November 2011
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Drug: Exenatide
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Mean amplitude of glycaemic excursions (MAGE) [ Time Frame: During 6-day treatment course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • homeostasis model assessment(HOMA) [ Time Frame: During 6-day treatment course ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Normal Saline

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473147

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

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01473147     History of Changes
Other Study ID Numbers: CMRPG3A0911
Study First Received: November 14, 2011
Last Updated: July 28, 2013
Health Authority: Taiwan : Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014