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

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Sun Yat-sen University

Status and phase

Unknown
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: CSII
Drug: Liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT01790308
13450149260

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

CSII
Active Comparator group
Description:
continuous subcutaneous insulin infusion for 2-4 weeks
Treatment:
Drug: CSII
Liraglutide
Active Comparator group
Description:
continuous subcutaneous insulin infusion for 2-4 weeks combined with combined with Liraglutide 0.6mg/d for 2-4 weeks and 1.2mg/d for next 9 weeks
Treatment:
Drug: Liraglutide
Drug: CSII

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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