Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes
Recruitment status was: Active, not recruiting
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.
|Type 2 Diabetes||Drug: conventional vs. flexible, intensive insulin therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes - a Non-Blinded, Randomized Controlled Cross-Over Clinical Trial of Metabolic Control and Patient Preference|
- glycosylated hemoglobin (GHb)
- mild and severe hypoglycemia, insulin dosage, blood pressure and body-mass-index (BMI).
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||December 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440284
|Medical School, Friedrich Schiller University Jena|
|Jena, Thuringia, Germany, 07740|
|Principal Investigator:||Christof Kloos, MD||Klinik Innere Medizin III, Medical School, Friedrich Schiller University|