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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790308

Enrollment

100

Registered

2013-02-13

Start date

2013-02-28

Completion date

2015-12-31

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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.

Detailed 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.

Interventions

DRUGCSII

continuous subcutaneous insulin infusion for 2\ 4 weeks

DRUGLiraglutide

CSII for 2\ 4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
the percentage of the patients who maintain glucose control 1 year after short intensive therapy	1 year

Secondary

Measure	Time frame
the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients	1 year
the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026