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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

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE May 2, 2014
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2014)
  • HbA1C level at every 3 months during the whole study [ Time Frame: 1 year ]
    HbA1C level at every 3 months during the whole study
  • mean glucose level during the follow without drug intervention [ Time Frame: 1 year ]
    mean glucose level during the follow without drug intervention
  • number of hypoglycemia and severe hypoglycemia during the study [ Time Frame: up to 1 year ]
    number of hypoglycemia and severe hypoglycemia during the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Exenatide
    Exenatide (10 ug/bid for 3 months)
    Other Name: GLP-1 receptor agonist
  • Drug: Metformin
    Metformin 850 mg/bid for 3 months
    Other Name: Glucophage
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Exenatide
  • 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)
    Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02129985
Other Study ID Numbers  ICMJE HS2014-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party xiaolong zhao, Huashan Hospital
Study Sponsor  ICMJE xiaolong zhao
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Huashan Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP