Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes

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.

Timeline

Start

2004-01

Primary completion

—

Completion

2004-12

Publications

• Kloos C, Samann A, Lehmann T, Braun A, Heckmann B, Muller UA. Flexible intensive versus conventional insulin therapy in insulin-naive adults with type 2 diabetes: an open-label, randomized, controlled, crossover clinical trial of metabolic control and patient preference. Diabetes Care. 2007 Dec;30(12):3031-2. doi: 10.2337/dc07-0397. Epub 2007 Aug 23. No abstract available.

Drugs

Indications