Status:
UNKNOWN
Flexible, Intensive vs. Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes
Lead Sponsor:
University of Jena
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Hypothesis In the undertaken study we tested the hypothesis that flexible, intensive and conventional insulin therapy in insulin-naive adults with type 2 diabetes are equally effective in regards to m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00440284
Start Date
January 1 2004
End Date
December 1 2004
Last Update
February 27 2007
Active Locations (1)
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1
Medical School, Friedrich Schiller University Jena
Jena, Thuringia, Germany, 07740