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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01471808
• Other study ID #: 13560475186
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 8, 2011
• Last updated: April 8, 2013
• Start date: October 2011
• Est. completion date: December 2021

Study information

• Verified date: April 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 336
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• CSII
continuous subcutaneous insulin infusion for 2~4 weeks
• CSII, Metformin, Pioglitazone
CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
• CSII, Sitagliptin
CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients		10 years	Yes
Primary	the improvement of ß-cell function after short intensive therapy in newly diagnosed type 2 diabetic patients		10 years	Yes
Primary	the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients		10 years	Yes
Secondary	the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients		10 years	Yes
Secondary	the effects of different interventions on ß-cell function in newly-diagnosed type 2 diabetic patients		10 years	Yes
Secondary	the effects of different interventions on the remission rate in newly-diagnosed type 2 diabetic patients		10 years	Yes