Type 2 Diabetes Mellitus Clinical Trial
Official title:
Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study
A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control
despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous
insulin infusion (CSII), using an external pump, could be a solution to improve diabetes
control.
The aim of this study is to compare, over a one-year period, the efficacy of CSII (with
aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x
2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus
regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline
(HbA1c>7 -10%).
Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent
signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are
instructed to use pump between V2 and V3.
Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic
medications except for metformin, which is followed up until the end of the study. Teaching
program on diabetes management (diet, physical activity and self-adjustment of insulin
doses). HbA1c, clinical and biological parameters. Questionnaires.
Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events
collection.
Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse
events collection.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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