Clinical trial NCT01574508: Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: efficacy
safety
intensive insulin therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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);
2. The anti-diabetic therapy is stable within 3 months before study screening;
3. Age: 25-65years, both gender, BMI: 20-35kg/m2;
4. Good compliance with the follow-up
5. Signed informed consent
6. HbA1c ≥ 8.0 % and ≤ 12%

Exclusion Criteria:

1. Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
2. For once daily insulin therapy: daily dose insulin therapy dosage \> 30IU
3. Having the history of using GLP-1 for therapy within 3 months before screening
4. Women in pregnancy or under breast feeding
5. Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
6. Allergic to study drugs
7. 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)
8. Other severe conditions which will put the patients in high risk during the study
9. Recently drug or alcohol abuse

Primary outcomes:
measure: Glycated hemoglobin levels
timeFrame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
measure: Glycated albumin levels
timeFrame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
Secondary outcomes:
measure: The glucose levels
timeFrame: During 2 weeks intensive treatment and 1 year after treatment
measure: Episode of hypoglycemia
timeFrame: During 2 weeks of intensive treatment and 1 year after treatment
measure: Body weight
timeFrame: During 2 weeks intensive treatment and 1 year after treatment
measure: Biochemical parameters and inflammatory factors
timeFrame: During 2 weeks intensive treatment and 1 year after treatment
measure: C peptide levels
timeFrame: During 2 weeks intensive treatment and 1 year after treatment
measure: Number of participants with adverse events
timeFrame: During 2 weeks intensive treatment and 1 year after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
state: Shanghai
Study officials:
References: