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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Jena
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• All patients with type 2 diabetes who failed to achieve their therapeutic goals under oral antidiabetic therapy and who were referred by local General Practitioners to the outpatient clinic for initiation of insulin therapy were candidates for inclusion in the study.

• Participants who agreed to participate in the study were recruited in consecutive order as they were referred to the out-patient clinic.

Exclusion Criteria:

• Not type 2 diabetes,

• Diabetes duration <2 years,

• Not insulin naive,

• Ineffective oral antidiabetic therapy < 3 months,

• GHb below 7 or above 11%,

• Age below 40 or above 65 years,

• Co-medication with corticosteroids,

• Pregnancy, severe mental or somatic diseases or

• Unwillingness to return for follow-up.