Insulin detemir 100units/ml solution for injection 3ml pre-filled disposable devices

Background: The evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. Methods: The Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137).We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. Discussions: This statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. Trial registration: of April 2008).

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PURPOSE: The objective of this retrospective study was to compare glycemic control, pregnancy outcomes, and neonatal outcomes in women with gestational diabetes mellitus (GDM) treated with (a) insulin detemir and (b) insulin neutral protamine Hagedorn (NPH). METHODS: A total of 192 women with GDM were included in the analysis. Ninety-eight women received detemir, while 94 women received NPH. Data regarding medical history, glycemic control, and time and mode of delivery, as well as neonatal outcomes, were recorded. RESULTS: Baseline characteristics were comparable between the two groups. There were no differences with respect to the week of insulin initiation, total insulin dose, duration of insulin therapy, daily insulin dose/weight in early and late pregnancy, or the number of insulin injections per day. Maternal overall weight gain during pregnancy and weight gain per week did not differ either. The detemir group had slightly lower HbA1c levels at the end of gestation [median: det 5.2% (33 mmol/mol) vs NPH 5.4% (36 mmol/mol), p=0.035). There were no cases of hypoglycemia or allergic reactions in the two groups. There were also no differences regarding neonatal outcomes according to the available data, given that data in some cases were missing. CONCLUSION: The use of insulin detemir was found to be equally effective and safe compared to NPH in women with GDM.

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BACKGROUND: Insulin detemir (IDet) is an insulin analog used to treat diabetes. IDet shows full efficacy but reduced potency compared to human insulin (HI) in both man and rat. In contrast, in pigs and dogs, IDet appears to have full in vivo potency. Non-receptor mediated degradation (NRMD) has previously been suggested as an explanation for the low potency of IDet, but this hypothesis has not been investigated further until now. Bacitracin is a nonspecific protease inhibitor which we hypothesized could inhibit NRMD of IDet in rats. RESEARCH DESIGN AND METHODS: Healthy male rats instrumented with permanent catheters underwent euglycemic clamp during constant infusion of either HI or IDet at effect-matched doses with co-infusion of vehicle or bacitracin. RESULTS: < 0.001) required to maintain euglycemic clamp indicates that the IDet rescued from NRMD indeed was active. No significant differences were detected with co-infusions of HI with either bacitracin or vehicle. CONCLUSIONS: A large proportion of NRMD of IDet which can be inhibited by bacitracin may partly explain the reduced potency of IDet observed in rats and likely also in man.

Abstract licence: CC BY-NC-ND

This real-world study assessed glycemic levels and further clinical outcomes, following initiation of detemir, in sub populations of people with T2D vulnerable to hypoglycemia. This retrospective cohort study included people registered in the United Kingdom Clinical Practice Research Datalink (CPRD) GOLD database who initiated detemir between January 2004 and December 2019. Analyses were stratified by age, previous insulin experience, and history of renal, liver or cardiovascular disease (CVD). In total, 8975 eligible study participants were identified (44.4%, aged ≥65 years; 23.7%, renal disease; 15.6%, CVD; 2.2%, liver disease; 53.3%, insulin-naïve). Six months post-index estimated changes (95% confidence intervals [CI]) in HbA1c and body weight were −1.00% (−1.1; −0.9) (−11 mmol/mol [−12; −9]) and 0.35 kg (0.03; 0.66), respectively. Rates of hypoglycemia were low, with no increase between pre- and post-index periods. Compared with pre-index, the mean number of oral glucose-lowering therapy prescriptions per person and mean number of people receiving each type of glucose-lowering therapy decreased post-index. Detemir appears to be an effective and well-tolerated treatment for T2D in older people, and those with CVD, renal disease or liver disease. • The effectiveness and safety of insulin detemir have been well established in clinical trials and observational studies • Evidence on the use of detemir in older people and those with comorbidities is limited • After initiation of detemir, patients with type 2 diabetes showed improved glycemic control • These findings may reassure prescribers that detemir is an effective treatment option for the above stated subpopulations

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