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Horm Metab Res 2006; 38(3): 172-177
DOI: 10.1055/s-2006-925222
Original Clinical
© Georg Thieme Verlag KG Stuttgart · New York

Once-daily Insulin Glargine Administration in the Morning Compared to Bedtime in Combination with Morning Glimepiride in Patients with Type 2 Diabetes: An Assessment of Treatment Flexibility

E.  Standl1 , S.  Maxeiner2 , S.  Raptis3 , HOE901/4009 Study Group
  • 1Munich Institute of Diabetes Research and 3 Medical Department, Krankenhaus München-Schwabing, Munich, Germany
  • 2Allgemeinmedizin/Prakt. Arzt, Bad Kreuznach-Bosenheim, Germany
  • 32nd Department of Internal Medicine, Research Institute and Diabetes Center, Athens University, Attikon University General Hospital, Athens, Greece
Further Information

Publication History

Received 15 June 2005

Accepted after revision 17 October 2005

Publication Date:
27 April 2006 (online)

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Abstract

Aims: To compare the incidence of nocturnal hypoglycemia and glycemic control following bedtime or morning insulin glargine (LANTUS®; glargine) plus glimepiride. Methods: In this 24-week, multinational, open, randomized study, 624 patients with type 2 diabetes poorly controlled on oral therapy received morning or bedtime glargine plus morning glimepiride (2, 3 or 4 mg) titrated to a target fasting blood glucose level ≤ 5.5 mmol/l. Results: The incidence of nocturnal hypoglycemia was equivalent between the two groups, with morning glargine non-inferior to bedtime (13.0 vs. 14.9 % of patients; between-treatment difference -1.9 %; one-sided 95 % confidence interval -100 %; 2.84 %). At endpoint, similar improvements in glycemic control were observed with morning compared to bedtime glargine: HbA1c: - 1.65 ± 1.21 vs. -1.57 ± 1.16 %; p = 0.42; fasting blood glucose: - 4.25 ± 2.82 vs. -4.48 ± 2.75 mmol/l; p = 0.08. The endpoint mean daily glargine dose was comparable (34.7 ± 17.4 vs. 32.4 ± 17.0 IU; p = 0.15), and there was no significant between-treatment difference in the change in body weight (2.1 vs. 1.8 kg; p = 0.39). Conclusions: Once-daily glargine can be administered in a flexible morning or bedtime regimen (plus morning glimepiride) to achieve good glycemic control without any difference in hypoglycemia.

Key words

Basal insulin - disease duration - flexibility - oral antidiabetic agent - titration

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Prof. E. Standl, M. D.

Munich Institute of Diabetes Research and 3 Medical Department · Krankenhaus München-Schwabing

Kölner Platz 1 · 80804 Munich · Germany ·

Phone: +49(89)30682523

Fax: +49(89)30683906

Email: eberhard.standl@lrz.uni-muenchen.de

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