OBJECTIVEIndividualization of therapy choices requires the prediction of likely response. Predictor and explanatory factors of change in HbA 1c were studied using data from a large observational study of starting insulin analog therapy (the A 1 chieve study).
RESEARCH DESIGN AND METHODSUnivariate analyses were performed for insulin-naive people and prior insulin users in the A 1 chieve study. Statistically significant factors were carried forward to baseline factor-only multivariate analyses ("predictor" analysis), and separately using all significant factors ("explanatory" analysis). Power was considered in terms of the variance explained.
RESULTSGeographical region, baseline HbA 1c level, lipid levels, and baseline insulin dose were the most powerful predictors of HbA 1c change (mean change 22.1% [223 mmol/mol]) observed in the univariate analysis (r 2 > 0.010, P < 0.001). However, although the predictor and explanatory multivariate models explained 62-82% of the variance in HbA 1c change, this was mainly associated with baseline HbA 1c (r 2 = 0.544-0.701) and region (r 2 = 0.014-0.037). Other factors were statistically significant but had low predictive power (r 2 < 0.010); in the explanatory analysis, this included end-of-study hypoglycemia (insulin-naive group), insulin dose, and health-related quality of life (r 2 < 0.001-0.006, P £ 0.007).
CONCLUSIONSMany factors can guide clinicians in predicting the response to starting therapy with insulin analogs, but many are interdependent and thus of poor utility. The factor explaining most of the variance in HbA 1c change is baseline HbA 1c level, with each increase of 1.0%-units (11 mmol/mol) providing a 0.7-0.8%-units (8-9 mmol/mol) greater fall. Other factors do not explain much of the remaining variance, even when including all end-of-trial measures.
Insulin degludec/insulin aspart (IDegAsp) is a modern coformulation of ultra-long-acting basal insulin degludec, with rapid-acting insulin aspart. IDegAsp provides effective, safe, well-tolerated glycemic control, with a low risk of hypoglycemia while allowing flexibility in meal patterns and timing of administration. This consensus statement describes a pragmatic framework to identify patients who may benefit from IDegAsp therapy. It highlights the utility of IDegAsp in type 2 diabetic patients who are insulin-naive, suboptimally controlled on basal or premixed insulin, or dissatisfied with basal–bolus regimens. It also describes potential IDegAsp usage in type 1 diabetic patients.
Aims:There is limited evidence with respect to the cost-effectiveness of starting insulin in people with diabetes outside the 'western' world. The aim of this study was to assess the cost-effectiveness of starting basal insulin treatment with insulin detemir in people with type 2 diabetes (T2D) inadequately controlled on oral glucose-lowering drugs (OGLDs) in Mexico, South Korea, India, Indonesia, and Algeria.
Methods:The IMS CORE Diabetes Model was used to project clinical and cost outcomes over a 30-year time horizon. Clinical outcomes, baseline characteristics and health state utility data were taken from the A 1 chieve study. A 1-year analysis was also conducted based on treatment costs and quality-of-life data. Incremental costeffectiveness ratios (ICERs) were expressed as a fraction of GDP per capita, and WHO-CHOICE recommendations (ICER53.0) used to define cost-effectiveness.
Results:Starting insulin detemir was associated with a projected increase in life expectancy (!1 year) and was considered cost-effective in all of the studied populations with ICERs of À0.02 (Mexico), 0.00 (South Korea), 0.48 (India), 0.12 (Indonesia), and 0.88 (Algeria) GDP/quality-adjusted life-year. Cost-effectiveness was maintained after conducting sensitivity analyses in the 30-year and 1-year analyses. A projected increase in treatment costs was partially offset by a reduction in complications. The difference in overall costs between insulin detemir and OGLDs alone was USD518, 1431, 3510, 15, and 5219, respectively.
Conclusion:Changes in clinical outcomes associated with starting insulin detemir in insulin-naïve individuals with T2D resulted in health gains that made the intervention cost-effective in five countries with distinct healthcare resources.
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