Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
Overview
- Phase
- Phase 4
- Intervention
- Transient Continuous Subcutaneous Insulin Infusion
- Conditions
- Type 2 Diabetes
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Glycated hemoglobin levels
- Last Updated
- 12 years ago
Overview
Brief Summary
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
Investigators
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage \< 30IU);
- •The anti-diabetic therapy is stable within 3 months before study screening;
- •Age: 25-65years, both gender, BMI: 20-35kg/m2;
- •Good compliance with the follow-up
- •Signed informed consent
- •HbA1c ≥ 8.0 % and ≤ 12%
Exclusion Criteria
- •Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- •For once daily insulin therapy: daily dose insulin therapy dosage \> 30IU
- •Having the history of using GLP-1 for therapy within 3 months before screening
- •Women in pregnancy or under breast feeding
- •Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
- •Allergic to study drugs
- •Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR \< 60ml/min)
- •Other severe conditions which will put the patients in high risk during the study
- •Recently drug or alcohol abuse
Arms & Interventions
Continuous Subcutaneous Insulin Infusion
CSII
Intervention: Transient Continuous Subcutaneous Insulin Infusion
Multiple Daily Insulin Injections
MDI
Intervention: Transient Multiple Daily Insulin Injections
Outcomes
Primary Outcomes
Glycated hemoglobin levels
Time Frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Glycated albumin levels
Time Frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Secondary Outcomes
- Biochemical parameters and inflammatory factors(During 2 weeks intensive treatment and 1 year after treatment)
- Body weight(During 2 weeks intensive treatment and 1 year after treatment)
- C peptide levels(During 2 weeks intensive treatment and 1 year after treatment)
- Number of participants with adverse events(During 2 weeks intensive treatment and 1 year after treatment)
- The glucose levels(During 2 weeks intensive treatment and 1 year after treatment)
- Episode of hypoglycemia(During 2 weeks of intensive treatment and 1 year after treatment)