Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Insulin; Insulin, Globin Zinc

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