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Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy (T2DMRS)

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ClinicalTrials.gov Identifier: NCT02129985
Recruitment Status : Unknown
Verified April 2014 by xiaolong zhao, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
The third people's Hospital Affiliated to Shanghai Jiao Tong University
Second Affiliated Hospital of Soochow University
The First Hospital of Guiyang Medical college
Fuling Central Hospital of Chongqing City
Taizhou Hospital
Shanghai Pudong New Area Gongli Hospital
Information provided by (Responsible Party):
xiaolong zhao, Huashan Hospital

Brief Summary:
Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Exenatide Drug: Metformin Phase 4

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 has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. 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 an 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. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study
Study Start Date : February 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exenatide
patients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months)
Drug: Exenatide
Exenatide (10 ug/bid for 3 months)
Other Name: GLP-1 receptor agonist

Active Comparator: Metformin
patients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months)
Drug: Metformin
Metformin 850 mg/bid for 3 months
Other Name: Glucophage




Primary Outcome Measures :
  1. time to glycaemic remission [ Time Frame: up to 1 year ]
    time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment

  2. remission rate of type 2 diabetes at a year. [ Time Frame: up to 1 year ]
    remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy


Secondary Outcome Measures :
  1. the beta cell function change [ Time Frame: 1 year ]
    the beta cell function change expressed by the ratio of proinsulin to insulin in fasting state and HOMA beta,the ratio of Glucose change to insulin change between at 30min and 0min time point of OGTT


Other Outcome Measures:
  1. HbA1C level at every 3 months during the whole study [ Time Frame: 1 year ]
    HbA1C level at every 3 months during the whole study

  2. mean glucose level during the follow without drug intervention [ Time Frame: 1 year ]
    mean glucose level during the follow without drug intervention

  3. number of hypoglycemia and severe hypoglycemia during the study [ Time Frame: up to 1 year ]
    number of hypoglycemia and severe hypoglycemia during the study



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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed type 2 diabetes without drug treatment
  • 25-70 years old age
  • Fasting glucose between 7.0-16.7mmol / L
  • BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
  • females who have no plan of pregnancy during the study

Exclusion Criteria:

  • acute or chronic complications of diabetes
  • myocardial infarction or cerebrovascular events within three months
  • serious gastrointestinal diseases
  • other serious concomitant diseases
  • liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
  • GAD antibodies positive
  • history of pancreatitis or pancreatic cancer;
  • pregnant or breastfeeding women.
  • severe hypertension (blood pressure> 180/110mmhg)
  • using corticosteroids, immunosuppressants and cytotoxic therapy.

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 ClinicalTrials.gov identifier (NCT number): NCT02129985


Contacts
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Contact: xiaolong zhao, MD. 86-18918067241 xiaolongzhao@163.com

Locations
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China, Shanghai
Xiaolong Zhao Recruiting
Jingan, Shanghai, China, 20041
Contact: xiaolong zhao, MD.    86-18918067241    xiaolongzhao@163.com   
Principal Investigator: xiaolong zhao, MD.         
Sponsors and Collaborators
xiaolong zhao
Shanghai Zhongshan Hospital
The third people's Hospital Affiliated to Shanghai Jiao Tong University
Second Affiliated Hospital of Soochow University
The First Hospital of Guiyang Medical college
Fuling Central Hospital of Chongqing City
Taizhou Hospital
Shanghai Pudong New Area Gongli Hospital

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Responsible Party: xiaolong zhao, Endocrinology department, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02129985     History of Changes
Other Study ID Numbers: HS2014-005
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by xiaolong zhao, Huashan Hospital:
the newly onset type 2 diabetes
short-term insulin treatment
exenatide sequential therapy
beta cell function
glycaemic remission

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists