Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes
Status:
Unknown status
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
Objective. Flexible, intensive insulin therapy (FIT) with pre-prandial regular insulin and
conventional insulin therapy (CIT) with twice daily premixed insulin are treatment options in
patients with type 2 diabetes who become insulin dependent. While intensive insulin therapy
can increase meal and life style flexibility, conventional therapy is easier to perform. The
aim of the study was to compare metabolic outcomes and patient preferences of both treatment
regimens.
Research Design and Methods. Non-blinded, randomized controlled cross-over clinical pilot
trial. Insulin naive participants who failed therapeutic goals under oral antidiabetic
therapy underwent FIT and CIT for two months. Patients completed standard Diabetes Treatment
and Teaching Programs (DTTP) and trained FIT and CIT. Main outcome measures were glycosylated
hemoglobin (GHb), mild and severe hypoglycemia, insulin dosage, blood pressure and
body-mass-index (BMI). Before/after and inter-group analyses were performed. Finally, therapy
preference was analyzed.