Type 2 Diabetes
Conditions
Keywords
the newly onset type 2 diabetes, short-term insulin treatment, exenatide sequential therapy, beta cell function, glycaemic remission
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.
Interventions
DRUGExenatide
Exenatide (10 ug/bid for 3 months)
DRUGMetformin
Metformin 850 mg/bid for 3 months
Sponsors
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
xiaolong zhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to glycaemic remission | 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. | up to 1 year | remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the beta cell function change | 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1C level at every 3 months during the whole study | 1 year | HbA1C level at every 3 months during the whole study |
| mean glucose level during the follow without drug intervention | 1 year | mean glucose level during the follow without drug intervention |
| number of hypoglycemia and severe hypoglycemia during the study | up to 1 year | number of hypoglycemia and severe hypoglycemia during the study |
Countries
China
Contacts
Primary Contactxiaolong zhao, MD.
Outcome results
None listed