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

NCT00440284 | Unknown Phase 3

• 1 other identifier: 1b
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

conventional insulin therapy; intensive insulin therapy; self-management; patient education; RCT; glycosylated hemoglobin; hypoglycemia; patient preference

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin (GHb)

Secondary Outcomes (1)

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

Interventions

conventional vs. flexible, intensive insulin therapy DRUG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Medical School, Friedrich Schiller University Jena

Jena, Thuringia, 07740, Germany

Location

Related Publications (1)

• Kloos C, Samann A, Lehmann T, Braun A, Heckmann B, Muller UA. Flexible intensive versus conventional insulin therapy in insulin-naive adults with type 2 diabetes: an open-label, randomized, controlled, crossover clinical trial of metabolic control and patient preference. Diabetes Care. 2007 Dec;30(12):3031-2. doi: 10.2337/dc07-0397. Epub 2007 Aug 23. No abstract available.

  PMID: 17717285 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Patient Preference

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christof Kloos, MD

  Klinik Innere Medizin III, Medical School, Friedrich Schiller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 27, 2007
• Study Start: January 1, 2004
• Study Completion: December 1, 2004
• Last Updated: February 27, 2007

Record last verified: 2007-02

Locations

DE (1)