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

NCT01473147 | Completed

• 1 other identifier: CMRPG3A0911
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

GLP-1 analogue; CSII; insulin; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Mean amplitude of glycaemic excursions (MAGE)

  During 6-day treatment course

Secondary Outcomes (1)

• homeostasis model assessment(HOMA)

  During 6-day treatment course

Study Arms (2)

GLP-1

ACTIVE COMPARATOR

Drug: Exenatide

Normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Exenatide DRUG

Exenatide 5 microgram bid sc.

Also known as: Byetta

GLP-1

Normal saline DRUG

Normal saline 2 u bid sc.

Normal saline

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Exenatide; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• CHIA-HUNG LIN, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2011-11

Locations

TW (1)