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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:

Study Description
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 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

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2004
Estimated Study Completion Date : December 2004

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. glycosylated hemoglobin (GHb)

Secondary Outcome Measures :
  1. mild and severe hypoglycemia, insulin dosage, blood pressure and body-mass-index (BMI).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Germany
Medical School, Friedrich Schiller University Jena
Jena, Thuringia, Germany, 07740
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Christof Kloos, MD Klinik Innere Medizin III, Medical School, Friedrich Schiller University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00440284     History of Changes
Other Study ID Numbers: 1b
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007

Keywords provided by University of Jena:
conventional insulin therapy
intensive insulin therapy
self-management
patient education
RCT
glycosylated hemoglobin
hypoglycemia
patient preference

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs