Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVETM study

Dornhorst, Anne; Lüddeke, Hans-Joachim; Sreenan, Séamus; Kozlovski, Plamen; Hansen, Jes B; Looij, B. J.; Meneghini, Luigi

doi:10.1111/j.1742-1241.2008.01715.x

Cited by 73 publications

(72 citation statements)

References 20 publications

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“…25,32,33 They are also consistent with clinical trial data of insulin detemir in comparison to other insulin types and can be relevant to routine clinical practice. 5,16,22 Consequently, insulin therapies like insulin detemir, which are better able to mimic the body's physiological responses, provide some scope for achieving an improved balance between glycemic control and treatment tolerability.…”

Section: Insulin Detemir In T2dm -Echtay Et Alsupporting

confidence: 63%

“…12 Although clinical trials support flexibility in injection frequency (once or twice daily), the pharmacodynamics profile of insulin detemir is best suited to once-daily use in persons with T2DM. 32 While data on frequency of injections was not collected in this study, similar studies with insulin detemir ± OADs showed that a once-daily injection was adequate for good glycemic control in the majority of persons (77% to 82%) with <25% persons requiring twice daily injections after 14 weeks of insulin detemir ± OADs. 25,31 Accordingly, an increase in the mean daily dose of insulin detemir from 17.5 ± .22 U/kg at baseline to 27.7 ± .34 U/kg at the end of the study in the Lebanese population is in line with the 52-week follow-up results of PREDICTIVE TM study.…”

Section: Insulin Detemir In T2dm -Echtay Et Almentioning

confidence: 99%

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Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup

et al. 2017

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Objective: To evaluate the effectiveness and safety of insulin detemir treatment as add-on therapy in a real-world setting of Lebanese insulin naïve persons, with type 2 diabetes poorly controlled on oral antidiabetic drugs (OADs). Methods:Our study was a prospective, observational study representing the Lebanese arm of the multinational prospective and observational study involving 2,155 persons across Near East countries, Lebanon, Pakistan, Israel and Jordan. Effectiveness endpoints were changes in HbA1c, fasting and post-prandial glucose (FPG, PPG) after 24 weeks of treatment with insulin detemir in eligible persons. Safety endpoints were number of hypoglycemic events, incidence of adverse drug reactions (ADRs), serious ADRs, adverse events, and body weight change between baseline and end of treatment.Results: 868 persons were included (mean age: 59.5 ± 10.4 years, men: 55.3%). Glycemic control improved with significant reduction in mean HbA1c from 9.7 ± 1.6% to 7.2 ± 1% (P<.0001). The percentage of persons who achieved the target of HbA1c<7% increased from .7% at baseline to 39% at week 24. Mean FPG decreased significantly from 213.7 ± 60.1 mg/dL to 120.3 ± 25.7 mg/dL (P<.001), and mean PPG from 271 ± 65.3 mg/dL to 158.1 ± 36.4 mg/dL (P<.0001). The rate of major hypoglycemic episodes decreased from .1498 at baseline to .0448 at week 24. Three adverse events but no ADR or serious ADR were reported. Body weight decreased from 80.4±13.2 Kg to 79.9±12.5 Kg (P<.0001). Conclusions:Initiating insulin detemir in a clinical health care setting among Lebanese with type 2 diabetes mellitus on OADs improves glycemic control with no increase in hypoglycemia, adverse events or weight compared with baseline. Ethn

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Section: Insulin Detemir In T2dm -Echtay Et Alsupporting

confidence: 63%

Section: Insulin Detemir In T2dm -Echtay Et Almentioning

confidence: 99%

Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup

et al. 2017

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“…Observational studies, including the A 1 chieve study, have provided support for this from routine clinical practice (9)(10)(11)(12).…”

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confidence: 97%

Predictive and Explanatory Factors of Change in HbA1c in a 24-Week Observational Study of 66,726 People With Type 2 Diabetes Starting Insulin Analogs

et al. 2014

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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.

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“…Accordingly, there is also a gain in life expectancy. Findings of improved metabolic outcomes in the short-term have been consistent with insulin detemir in T2D in both RCTs and observational studies, although the extent of the improvement is often not as large in the RCTs as in the studies done in routine clinical practice such as A 1 chieve 5,[13][14][15]17,19,21,23 . A 30-year time horizon was judged realistic, as most people in the modeled cohort would be expected to die within that time, and such a time horizon will allow the capturing of the relevant costs and outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…In randomized clinical trials (RCTs) in insulin-naïve people with T2D, basal insulin analogs have demonstrated better glycemic control with a lower risk of hypoglycemia compared with human neutral protamine Hagedorn (NPH) insulin [13][14][15][16][17][18] . Furthermore, the clinical effectiveness of basal insulin analogs in T2D has been demonstrated in real-life observational studies 5,[19][20][21][22][23] . Observational data are often collected from large heterogeneous populations that help enhance the generalizability of the clinical findings of RCTs.…”

Section: Introductionmentioning

confidence: 99%

An analysis of the cost-effectiveness of starting insulin detemir in insulin-naïve people with type 2 diabetes

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Baik

Gálvez

et al. 2014

Journal of Medical Economics

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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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Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVETM study

Cited by 73 publications

References 20 publications

Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup

Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup

Predictive and Explanatory Factors of Change in HbA1c in a 24-Week Observational Study of 66,726 People With Type 2 Diabetes Starting Insulin Analogs

An analysis of the cost-effectiveness of starting insulin detemir in insulin-naïve people with type 2 diabetes

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