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

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ClinicalTrials.gov Identifier: NCT01790308
Recruitment Status : Unknown
Verified February 2013 by Yanbing Li, Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
First Posted : February 13, 2013
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: CSII Drug: Liraglutide Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CSII
continuous subcutaneous insulin infusion for 2-4 weeks
 Drug: CSII
continuous subcutaneous insulin infusion for 2~4 weeks
Active Comparator: Liraglutide
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
 Drug: CSII
continuous subcutaneous insulin infusion for 2~4 weeks

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


Outcome Measures
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Primary Outcome Measures :
  1. the percentage of the patients who maintain glucose control 1 year after short intensive therapy [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients [ Time Frame: 1 year ]
  2. the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790308


Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yanbing Li, MD Ministry of Education
More Information
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Responsible Party: Yanbing Li, director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01790308    
Other Study ID Numbers: 13450149260
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists