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

Abstract

ABSTRACTObjective: 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, DenmarkResearch 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/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.