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Exp Clin Endocrinol Diabetes 2008; 116(1): 58-64
DOI: 10.1055/s-2007-985367
Article

© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Treatment Satisfaction of Once-daily Insulin Glargine Plus One or Two Oral Antidiabetic Agents Versus Continuing Premixed Human Insulin in Patients with Type 2 Diabetes Previously on Long-term Conventional Insulin Therapy: The SWITCH Pilot Study

R. Schiel 1 , 2 , U. A. Müller 1
  • 1Department of Internal Medicine III, University of Jena Medical School, Jena, Germany
  • 2Department of Diabetes and Metabolic Diseases, MEDIGREIF Group, Inselklinik Heringsdorf GmbH, Seeheilbad Heringsdorf, Germany
Further Information

Publication History

received 26.07.2006 first decision 28.09.2006

accepted 12.06.2007

Publication Date:
31 October 2007 (online)

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Abstract

Background: Addition of the long-acting basal human insulin analogue insulin glargine (LANTUS®) to the treatment regimen of patients with inadequate glycaemic control on oral antidiabetic drugs (OADs) alone has previously been evaluated as effective, safe and convenient. This pilot study aimed to establish whether insulin glargine plus OADs is effective in Type 2 diabetes patients previously poorly controlled on premixed insulin therapy.

Methods: In an open, controlled, randomized, parallel-group, single-centre, 16-week pilot study, 52 patients (age 65.6±9.2 years; diabetes duration 15.3±7.6 years; insulin therapy duration 4.2±1.7 years, body mass index 31.4±2.9 kg/m2) with Type 2 diabetes (HbA1c≥8.0%) on premixed human insulin (75/25 or 70/30) were randomized to once-daily morning insulin glargine plus glimepiride (Group A; n=17), insulin glargine plus glimepiride and metformin (Group B; n=18) or premixed insulin (Group C; n=17). Glycaemic control and incidence of hypoglycaemia were evaluated.

Results: HbA1c decreased significantly from baseline in Groups A and B, but not in Group C; (Group A: 7.87±0.66%, -0.35%, p=0.013; Group B: 7.44±0.92%, -0.69%, p=0.0057; Group C: 7.83±1.13%, -0.25%, p=0.32). There were no between-treatment differences at endpoint in HbA1c, fasting blood glucose, mean daily blood glucose or symptomatic hypoglycaemia (mean events/patient: Group A, 2.2; Group B, 2.3; Group C, 2.0). At endpoint, 88% of patients in Group A, 81% in Group B and 94% in Group C opted to continue with their assigned regimen.

Conclusions: This pilot study is the first prospective study to show that switching from premixed insulin to insulin glargine plus OAD treatment resulted in similar glycaemic control and treatment satisfaction. The results support the need for prospective examination in a larger-scale clinical study in patients with long-standing Type 2 diabetes and sub-optimal glycaemic control previously using a conventional premixed insulin regimen.

Key words

insulin glargine - glimepiride - metformin - hypoglycaemia - treatment satisfaction

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Correspondence

R. Schiel MD, PhD 

Medical Director and Head of the Department of Diabetes and Metabolic Diseases

Inselklinik Heringsdorf GmbH

Seeheilbad Heringsdorf

Germany

Phone: +49/38/378 780 50 0

Fax: +49/38/378 780 55 5

Email: inselklinik.schiel@medigreif.de

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