Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

NCT ID: NCT01574508

Last Updated: 2013-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Subcutaneous Insulin Infusion

CSII

Group Type: EXPERIMENTAL

Transient Continuous Subcutaneous Insulin Infusion

Intervention Type: DRUG

Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.

Multiple Daily Insulin Injections

MDI

Group Type: ACTIVE_COMPARATOR

Transient Multiple Daily Insulin Injections

Intervention Type: DRUG

Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital

Interventions

Transient Continuous Subcutaneous Insulin Infusion

Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.

Intervention Type: DRUG

Transient Multiple Daily Insulin Injections

Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital

Intervention Type: DRUG

Other Intervention Names

CSII; MDI

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Guang Ning

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guang Ning, Professor

Role: primary

feifei1116@hotmail.com

8621-64370045 ext. 665344

Other Identifiers

CCEMD012

Identifier Type: -

Identifier Source: org_study_id