Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00440284|
Recruitment Status : Unknown
Verified February 2007 by University of Jena.
Recruitment status was: Active, not recruiting
First Posted : February 27, 2007
Last Update Posted : February 27, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: conventional vs. flexible, intensive insulin therapy||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2004|
|Study Completion Date :||December 2004|
- glycosylated hemoglobin (GHb)
- mild and severe hypoglycemia, insulin dosage, blood pressure and body-mass-index (BMI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|