Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Transient Multiple Daily Insulin Injections; Drug: Transient Continuous Subcutaneous Insulin Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01574508

CCEMD012

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Continuous Subcutaneous Insulin Infusion

Experimental group

Description:

CSII

Treatment:

Drug: Transient Continuous Subcutaneous Insulin Infusion

Multiple Daily Insulin Injections

Active Comparator group

Description:

MDI

Treatment:

Drug: Transient Multiple Daily Insulin Injections