Effects of Different Early Intensive Therapies on Long-term β-cell Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Official Title
-----------------
Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: CSII
* Drug: CSII, Metformin, Pioglitazone
* Drug: CSII, Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed type 2 diabetes fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L body mass index (BMI) ranging from20～35kg/m2 Antihyperglycaemic and antihyperlipidemic medication-naive patients Exclusion Criteria: having any severe acute or chronic diabetic complications renal dysfunction, blood creatinine≥150µmol/L blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT) • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months chronic or acute pancreatic disease severe systematic diseases or malignant tumor female patients incline to be pregnant being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSII<br>continuous subcutaneous insulin infusion | Drug: CSII<br>* continuous subcutaneous insulin infusion for 2 4 weeks<br>|
| Active Comparator: Metformin & Pioglitazone<br>CSII combined with metformin and pioglitazone | Drug: CSII, Metformin, Pioglitazone<br>* CSII for 2 4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.<br>|
| Active Comparator: Sitagliptin<br>CSII combined with sitagliptin 100mg/d | Drug: CSII, Sitagliptin<br>* CSII for 2 4 weeks combined with sitagliptin 100mg/d for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients |  | 10 years | 
| the improvement of β-cell function after short intensive therapy in newly diagnosed type 2 diabetic patients |  | 10 years | 
| the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients |  | 10 years | 
| the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients |  | 10 years | 
| the effects of different interventions on the remission rate in newly-diagnosed type 2 diabetic patients |  | 10 years |