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
- Hannele Yki-Järvinen, MD, FRCP1,
- Leena Juurinen, MD12,
- Michael Alvarsson, MD3,
- Tord Bystedt, MD3,
- Ian Caldwell, MD4,
- Melanie Davies, MD5,
- Sanni Lahdenperä, MD6,
- Gil Nijpels, MD7 and
- Markku Vähätalo, MD8
- 1University of Helsinki, Helsinki, Finland
- 2Minerva Institute for Medical Research, Helsinki, Finland
- 3Department of Endocrinology, Metabolism, and Diabetes, Karolinska University Hospital, Stockholm, Sweden
- 4Swan Lane Medical Centre, Bolton, U.K
- 5Leicester Royal Infirmary, Leicester, U.K
- 6Sanofi-Aventis, Helsinki, Finland
- 7VU University Medical Center, Amsterdam, the Netherlands
- 8Turku 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
Abstract
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.
- ALT, alanine aminotransferase
- DTSQ, Diabetes Treatment Satisfaction Questionnaire
- FPG, fasting plasma glucose
Footnotes
-
Published ahead of print at http://care.diabetesjournals.org on 23 March 2007. DOI: 10.2337/dc06-1357. Clinical trial reg. no. ISRTN09079822, clinicaltrials.gov.
H.Y.-J. has acted as a consultant or speaker for Amylin, Astra-Zeneca, Aventis, Lilly, Merck, MSD, Pfizer, and Sanofi-Aventis and has received grant support for investigator-initiated trials from Astra-Zeneca, Aventis, Eli Lilly, Novartis, and Roche. M.D. has acted as a consultant and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, and Eli Lilly and has received grants in support of investigator and internal trials from Servier, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
-
- Accepted March 13, 2007.
- Received November 6, 2006.
- DIABETES CARE
