Effects of Different Early Intensive Therapies on Long-term β-cell Function
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: CSII Drug: CSII, Metformin, Pioglitazone Drug: CSII, Sitagliptin |
Phase | Phase 4 |
Sponsor | Sun Yat-sen University |
Responsible Party | Sun Yat-sen University |
ClinicalTrials.gov Identifier | NCT01471808 |
First Received | November 8, 2011 |
Last Updated | April 8, 2013 |
Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | November 8, 2011 |
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Last Updated Date | April 8, 2013 |
Start Date | October 2011 |
Estimated Primary Completion Date | December 2021 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effects of Different Early Intensive Therapies on Long-term β-cell Function |
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Official Title | Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: CSII continuous subcutaneous insulin infusion for 2~4 weeks Drug: CSII, Metformin, Pioglitazone CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months. Drug: CSII, Sitagliptin CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 336 |
Estimated Completion Date | December 2021 |
Estimated Primary Completion Date | December 2020 |
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 |
Gender | Both |
Ages | 25 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01471808 |
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Other Study ID Numbers | 13560475186 |
Has Data Monitoring Committee | Yes |
Information Provided By | Sun Yat-sen University |
Study Sponsor | Sun Yat-sen University |
Collaborators | Not Provided |
Investigators | Principal Investigator: Yanbin Li, MD Ministry of Education |
Verification Date | April 2013 |