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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CSII

continuous subcutaneous insulin infusion

Group Type ACTIVE_COMPARATOR

CSII

Intervention Type DRUG

continuous subcutaneous insulin infusion for 2\~4 weeks

Metformin & Pioglitazone

CSII combined with metformin and pioglitazone

Group Type ACTIVE_COMPARATOR

CSII, Metformin, Pioglitazone

Intervention Type DRUG

CSII for 2\~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.

Sitagliptin

CSII combined with sitagliptin 100mg/d

Group Type ACTIVE_COMPARATOR

CSII, Sitagliptin

Intervention Type DRUG

CSII for 2\~4 weeks combined with sitagliptin 100mg/d for 3 months

Interventions

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CSII

continuous subcutaneous insulin infusion for 2\~4 weeks

Intervention Type DRUG

CSII, Metformin, Pioglitazone

CSII for 2\~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.

Intervention Type DRUG

CSII, Sitagliptin

CSII for 2\~4 weeks combined with sitagliptin 100mg/d for 3 months

Intervention Type DRUG

Eligibility Criteria

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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 from21～35kg/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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No