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Initiate Insulin by Aggressive Titration and Education (INITIATE)

A randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups

¹ University of Helsinki, Helsinki, Finland
² Minerva Institute for Medical Research, Helsinki, Finland
³ Department of Endocrinology, Metabolism, and Diabetes, Karolinska University Hospital, Stockholm, Sweden
⁴ Swan Lane Medical Centre, Bolton, U.K
⁵ Leicester Royal Infirmary, Leicester, U.K
⁶ Sanofi-Aventis, Helsinki, Finland
⁷ VU University Medical Center, Amsterdam, the Netherlands
⁸ Turku Health Center, Turku, Finland

Address correspondence and reprint requests to Hannele Yki-Järvinen, MD, FRCP, University of Helsinki, P.O. Box 700, Room C426B, FIN-00029 HUCH, Helsinki, Finland. E-mail: ykijarvi{at}cc.helsinki.fi

OBJECTIVE—Insulin is often postponed for years because initiation is time-consuming. We sought to compare initiation of insulin individually and in groups with respect to change in A1C and several other parameters in type 2 diabetic patients.

RESEARCH DESIGN AND METHODS—A randomized (1:1), multicenter, two-arm, parallel design study with a recruiting period of up to 14 weeks and a 24-week treatment period. Either in groups of 4–8 or individually, using the same personnel and education program, 121 insulin-naive type 2 diabetic patients with an A1C of 7.0–12.0% were randomized to initiate bedtime insulin glargine. The patients visited the treatment center before and at the time of insulin initiation and at 6, 12, and 24 weeks. Patients self-adjusted the insulin dose to achieve a fasting plasma glucose 4.0–5.5 mmol/l.

RESULTS—At 24 weeks, mean ± SE A1C had decreased from 8.7 ± 0.2 to 6.9 ± 0.1% in those treated individually and from 8.8 ± 0.2 to 6.8 ± 0.1% in those in groups (not significant [NS]). Insulin doses averaged 62 ± 5 IU and 56 ± 5 IU at 24 weeks (NS), respectively. The frequency of hypoglycemia was similar. The total time (visits and phone calls) spent in initiating insulin in the patients in groups (2.2 ± 0.1 h) was 48% less than in those treated individually (4.2 ± 0.2 h). Diabetes treatment satisfaction improved significantly in both sets of patients.

CONCLUSIONS—Similar glycemic control and treatment satisfaction can be achieved by initiating insulin in groups and individually. Starting insulin in groups takes one-half as much time as individual initiation.

Abbreviations: ALT, alanine aminotransferase • DTSQ, Diabetes Treatment Satisfaction Questionnaire • FPG, fasting plasma glucose

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