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Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

This study is currently recruiting participants.
Verified January 2013 by The First Affiliated Hospital of Xiamen University
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier:
NCT01776788
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: insulin lispro injection, exenatide injection
Drug: insulin lispro injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy on β-cell Function and Glycemic Remission Rate in Newly Diagnosed Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The First Affiliated Hospital of Xiamen University:

Primary Outcome Measures:
  • the glycemic remission rate in different groups [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the improvement of β-cell function in different groups. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • the time of glycemic remission in different groups [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin lispro injection, exenatide injection Drug: insulin lispro injection, exenatide injection
First, Patients in the exenatide group will receive short-term continuous subcutaneous insulin (CSII)therapy. The doses will be titrated every day in order to attain the glycaemic goal which is defined as a fasting capillary blood glucose of less than 6.1 mmol/L and capillary blood glucose at 2 h after each of three meals of less than 8.0 mmol/L. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then, patients will Sequential be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 8 weeks. After interventions will be stopped, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly
Active Comparator: insulin lispro injection Drug: insulin lispro injection
Patients in the control group will receive insulin with an insulin pump. The doses will be titrated every day in order to attain the glycaemic goal. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then interventions will be stop, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly.

Detailed Description:

The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus, irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches. Short-term intensive insulin therapy of newly diagnosed type 2 diabetes will improve beta-cell function and usually leading to a temporary remission time. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is synthetic exendin-4, GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. This current study is thus designed to evaluate effect of short-term intensive insulin sequential exenatide therapy model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. newly-diagnosed type 2 diabetic patients, drug naïve
  2. age 30~70 years
  3. FPG 7.0~16.7mmol/L
  4. BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
  5. female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion Criteria:

  1. acute or severe chronic diabetic complications
  2. Recently suffered from MI or CVA.
  3. severe gastrointestinal disease
  4. other severe intercurrent illness
  5. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
  6. tested positive for glutamic acid decarboxylase antibody
  7. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
  8. history of pancreatitis
  9. Pregnant or lactation women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776788

Contacts
Contact: Xiu-lin Shi, MD 0592-2137710 shixiulin2002@163.com

Locations
China, Fujian
The first afilliated hospital of Xiamen university Recruiting
Xiamen, Fujian, China, 361003
Contact: Xue-jun Li, MD,PHD     13860451316     lixuejue99@yahoo.com.cn    
Principal Investigator: Xue-jun Li, MD,PhD            
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University
Investigators
Study Director: Xue-jun Li, MD,PhD The First Affiliated Hospital of Xiamen University, China
  More Information

No publications provided

Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT01776788     History of Changes
Other Study ID Numbers: bmd-201207-xm
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013