Once-daily insulin detemir in a cohort of insulin-naïve patients with type 2 diabetes: a sub-analysis from the PREDICTIVE study

ABSTRACT

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.

* Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation; Novo Nordisk A/S, Bagsvaerd, Denmark

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 HbA_1C 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. HbA_1C decreased by a mean 1.25% (SD ± 1.25%; p < 0.0001), with 30% of patients (n = 383) achieving HbA_1C <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/m².

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.

Key words: :

• Glycemic control
• Insulin detemir
• Insulin therapy
• Once daily
• Type 2 diabetes
• Weight gain

Acknowledgments

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.

Notes

* Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation; Novo Nordisk A/S, Bagsvaerd, Denmark

* Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation; Novo Nordisk A/S, Bagsvaerd, Denmark

† Levemir® FlexPen® 100 U/mL, 3 mL, Novo Nordisk A/S, Bagsvaerd, Denmark