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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University of Jena.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00440284
First received: February 21, 2007
Last updated: February 23, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: conventional vs. flexible, intensive insulin therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • glycosylated hemoglobin (GHb)

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

Estimated Enrollment: 38
Study Start Date: January 2004
Estimated Study Completion Date: December 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00440284     History of Changes
Other Study ID Numbers: 1b
Study First Received: February 21, 2007
Last Updated: February 23, 2007
Health Authority: Germany: Ethics Commission

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014