Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01790308
• Other study ID #: 13450149260
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: February 11, 2013
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: February 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 liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Description:

The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.liraglutide 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: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• newly diagnosed type 2 diabetes

• fasting blood glucose (FBG) level ranging from 7.0-16.7mmol/L

• body mass index (BMI) ranging from 21-35kg/m2

• antihypercaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

• having any severe acute or chronic diabetic complications

• renal dysfunction, blood creatinine>150umol/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 systemic diseases or malignant tumor

• female patients incline to be pregnant

• being treated with corticosteriod, 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
• Liraglutide
CSII for 2~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 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	the percentage of the patients who maintain glucose control 1 year after short intensive therapy		1 year	Yes
Secondary	the acute insulin response reflected ß-cell function of different interventions in newly-diagnosed type 2 diabetic patients		1 year	Yes
Secondary	the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients		1 year	Yes