TY - JOUR
T1 - Once-daily insulin detemir in a cohort of insulin-naïve patients with type 2 diabetes
T2 - A sub-analysis from the PREDICTIVE study
AU - Meneghini, Luigi F.
AU - Dornhorst, A.
AU - Sreenan, S.
N1 - Funding Information:
Declaration of interest: Funding for this study was provided by Novo Nordisk A/S, Bagsvaerd, Denmark. A. D. and S. S. are principal investigators in the PREDICTIVE study, which is sponsored by Novo Nordisk. L. F. M. has received support from Novo Nordisk, Eli Lilly, Sanofi-Aventis, Amylin, Merck, NIPRO Systems, and Medtronic. A. D. has received speaker fees from Pfizer, GlaxoSmithKline and Novo Nordisk, and consultancy fees from Novartis, GlaxoSmithKline and Novo Nordisk. S. S. has received support from Novo Nordisk A/S, Eli Lilly, and AstraZeneca. The authors acknowledge the assistance of Stephanie Finucane and Lisa Sullivan of Watermeadow Medical, USA in the preparation of this paper. The preparation of this article was supported by Novo Nordisk. Members of the PREDICTIVE Study Group: S. Aczel; J. Louis Chiasson; A. Dornhorst; B. Gallwitz; F. Hernandez; M. Honka; A. Johnson; A. King; L. Landstedt-Hallin; B. Looij; H. Lüddeke; M. Marre; S. Maxeiner; C. F. Montañana; A. Philotheou; A. Robinson; S. Sreenan; M. A. Tambascia; B. Trippe; A. Tsur; A. Virkamäki; M. Yenigun.
PY - 2009/4
Y1 - 2009/4
N2 - Objective: PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-naïve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. Research design and methods: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-naïve patients with T2DM (mean age 60.8 ± 10.9 years, BMI 29.8 ± 4.8 kg/m2, and HbA1C 8.82 ± 1.50%). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. Main outcome measures: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. Results: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA1C decreased by a mean 1.25% (SD ± 1.25%; p<0.0001), with 30% of patients (n = 383) achieving HbA1C <7% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD ± 2.93; p<0.0001) and -0.48 mmol/L (SD ± 1.03; p<0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD ± 3.3; p<0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m2). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m 2. Conclusions: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-naïve patients uncontrolled on OADs.
AB - Objective: PREDICTIVE* is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-naïve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. Research design and methods: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-naïve patients with T2DM (mean age 60.8 ± 10.9 years, BMI 29.8 ± 4.8 kg/m2, and HbA1C 8.82 ± 1.50%). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. Main outcome measures: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. Results: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA1C decreased by a mean 1.25% (SD ± 1.25%; p<0.0001), with 30% of patients (n = 383) achieving HbA1C <7% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD ± 2.93; p<0.0001) and -0.48 mmol/L (SD ± 1.03; p<0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD ± 3.3; p<0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m2). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m 2. Conclusions: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-naïve patients uncontrolled on OADs.
KW - Glycemic control
KW - Insulin detemir
KW - Insulin therapy
KW - Once daily
KW - Type 2 diabetes
KW - Weight gain
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U2 - 10.1185/03007990902840871
DO - 10.1185/03007990902840871
M3 - Article
C2 - 19281426
AN - SCOPUS:67649344521
SN - 0300-7995
VL - 25
SP - 1029
EP - 1035
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 4
ER -