Abstract | OBJECTIVE: METHODS: This was an observational cohort study conducted in 10 countries using insulin detemir. Data were collected at 3 clinic visits (baseline, 12-week interim, and 24-week final visit). RESULTS: A total of 13,526 (77.9%) patients were included in the glycosylated hemoglobin A1c (HbA1c) subset analysis. Patients were grouped according to pre- insulin HbA1c values as follows: HbA1c <7.6% (n = 2,797); HbA1c 7.6-9% (n = 5,366), and HbA1c >9% (n = 5,363). A total of 27 patients experienced serious adverse drug reactions (SADRs) and/or severe hypoglycemia (3, 10, and 11 patients with pre- insulin HbA1c <7.6%, 7.6-9.0%, and >9.0%, respectively). All patient subgroups realized improvements in HbA1c, with the pre- insulin HbA1c >9% subgroup having the largest HbA1c reduction (-2.4% versus -0.9% and -0.2% for HbA1c subgroups 7.6-9% and <7.6%, respectively). In the total cohort (n = 17,374), the incidence of severe hypoglycemia decreased from 4 events per 100 person years to <1 event per 100 person years by final visit; the incidence of minor hypoglycemia increased from 1.6 to 1.8 events per person year. CONCLUSIONS: In this study, insulin initiation was delayed until late in disease course, and overall concordance with internationally recognized guidelines was low. The initiation of once-daily insulin detemir was associated with substantial improvements in glycemic control and was not associated with an increase in severe hypoglycemia or weight gain.
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Authors | Salvatore Caputo, Henning Andersen, Marcel Kaiser, Eddy Karnieli, Luigi F Meneghini, Anne Louise Svendsen, SOLVE Study Group |
Journal | Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
(Endocr Pract)
2013 May-Jun
Vol. 19
Issue 3
Pg. 462-70
ISSN: 1934-2403 [Electronic] United States |
PMID | 23337147
(Publication Type: Journal Article)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Insulin, Long-Acting
- Insulin Detemir
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Topics |
- Aged
- Blood Glucose
(drug effects, metabolism)
- Drug Administration Schedule
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Insulin Detemir
- Insulin, Long-Acting
(administration & dosage, therapeutic use)
- Male
- Middle Aged
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