Clinical trial NCT02129985: Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: the newly onset type 2 diabetes
short-term insulin treatment
exenatide sequential therapy
beta cell function
glycaemic remission
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: The third people's Hospital Affiliated to Shanghai Jiao Tong University
name: Second Affiliated Hospital of Soochow University
name: The First Hospital of Guiyang Medical college
name: Fuling Central Hospital of Chongqing City
name: Taizhou Hospital
name: Shanghai Pudong New Area Gongli Hospital
First posted: 2014-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: time to glycaemic remission
timeFrame: up to 1 year
measure: remission rate of type 2 diabetes at a year.
timeFrame: up to 1 year
Secondary outcomes:
measure: the beta cell function change
timeFrame: 1 year
Other outcomes:
measure: HbA1C level at every 3 months during the whole study
timeFrame: 1 year
measure: mean glucose level during the follow without drug intervention
timeFrame: 1 year
measure: number of hypoglycemia and severe hypoglycemia during the study
timeFrame: up to 1 year
Locations:
city: Jingan
country: China
facility: Xiaolong Zhao
state: Shanghai
Study officials:
References: