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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: CSII; Drug: CSII, Metformin, Pioglitazone; Drug: CSII, Sitagliptin

• Registration Number: NCT01471808
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSII	CSII	continuous subcutaneous insulin infusion
Metformin & Pioglitazone	CSII, Metformin, Pioglitazone	CSII combined with metformin and pioglitazone
Sitagliptin	CSII, Sitagliptin	CSII combined with sitagliptin 100mg/d

Primary Outcome Measures

Name	Time	Method
glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients	1 years
the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients	1 years

Secondary Outcome Measures

Name	Time	Method
the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients	1 years