Use Of Insulin Detemir Research Articles

Comparison of treatment with insulin detemir and NPH in women with gestational diabetes mellitus: glycemic control and pregnancy outcomes. A retrospective study

PurposeThe 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).MethodsA 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.ResultsBaseline 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.ConclusionThe use of insulin detemir was found to be equally effective and safe compared to NPH in women with GDM.

Доказанная эффективность и безопасность применения инсулина деглудек при лечении сахарного диабета 1 типа у беременных

Diabetes mellitus (DM) remains a disease that determines the high frequency of obstetric and perinatal complications. Achieving the physiological values of glycemia as the main condition for the successful course and outcomes of pregnancy in women with diabetes remains a difficult task to date. To improve the quality of treatment of patients with DM 1 type, the method of basic bolus insulin therapy has been used for more than 30 years. Therefore, the emergence of new effective and safe insulins is extremely important for improving pregnancy outcomes in patients with diabetes. Insulin degludec is an analogue of basal insulin of the new generation with improved pharmacokinetic and pharmacodynamics profiles compared to analogues of basal insulins of the previous generation, however, there was insufficient data on its use during pregnancy. This article presents the results of an open international randomized controlled study of EXPECT no less effective use of insulin degludec during pregnancy, which took place in 14 countries in 56 research centers, 8 of them in Russia. Of the 225 women with DM 1 type who participated in the study, 67 were from Russia. The EXPECT study compared the efficacy and safety of insulin degludec with insulin detemir (both in combination with insulin aspart) in pregnant women with DM 1 type. Insulin detemir was chosen as a comparison drug, since it is the first basal insulin analog approved for use during pregnancy and most often recommended as a first-line drug when choosing long-acting insulin for the treatment of diabetes in pregnant women. Material and methods. The study included women over the age of 18 with DM 1 type, whose gestation period ranged from 8 (+0 days) to 13 (+6 days) weeks and who were just planning a pregnancy. The study participants (1:1) were randomized using an interactive Internet system for the use of insulin degludec at a dose of 100 U/ml once a day or insulin detemir at a dose of 100 U/ml once or twice a day, while both drugs were taken in combination with insulin aspart at a dose of 100 U/ml. Pregnant women received the study drug at randomization, throughout the entire period of pregnancy and up to 28 days after delivery (the end of the study). Women who were not pregnant at the time of randomization started taking the study drug before conception. The primary endpoint is the last scheduled measurement of glycated hemoglobin (HbA1c) before childbirth (a field of at least 0.4% efficiency for degludec compared to detemir). Secondary endpoints are efficacy, safety for the mother, and pregnancy outcomes. The primary endpoint was evaluated in all randomized women who were pregnant during the study. Safety – for all participants who were pregnant during the study and received at least one dose of the study drug. This study is registered on the website ClinicalTrials.gov numbered NCT03377699 and currently completed. Results. From November 22, 2017 to November 8, 2019, out of 296 screened women, 225 were randomized for insulin degludec (n = 111) or insulin detemir (n = 114). The average HbA1c value at the initial stage of pregnancy in the degludec insulin group was 6.6% with a standard deviation (SD) of 0.6%, in the detemir insulin group -6.5% with SD of 0.8%. In the degludec insulin group, the average value of the last planned measurement of HbA1c before childbirth was 6.2% (SD – 0.07%; 45 mmol/mol), in the detemir insulin group – 6.3% (SD – 0.07%; 46 mmol/mol). The estimated difference between the treatment groups is -0.11% (95% CI -0.31–0.08); -1.2 mmol/mol (95% CI -3.4–0.9); p < 0.0001 which confirms the equally effective effectiveness of insulin degludec. When using insulin degludec, no additional safety-related problems were reported compared to the use of insulin detemir.

Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial

Insulin detemir, being used increasingly during pregnancy, may have pharmacologic benefits compared with neutral protamine Hagedorn. We evaluated the probability that compared with treatment with neutral protamine Hagedorn, treatment with insulin detemir reduces the risk for adverse neonatal outcome among individuals with type 2 or overt type 2 diabetes mellitus (gestational diabetes mellitus diagnosed at <20 weeks' gestation). We performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation. Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme. The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia. The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay. The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications. We used the Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with insulin detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890). There were 108 women randomized in this trial (57 in insulin detemir and 51 in neutral protamine Hagedorn), and 103 women were available for analysis of the primary outcome (n=5 for pregnancy loss before 24 weeks' gestation). Bayesian analysis indicated an 87% posterior probability of reduced primary outcome with insulin detemir compared with neutral protamine Hagedorn (posterior adjusted relative risk, 0.88; 95% credible interval, 0.61-1.12). Bayesian analyses for secondary outcomes showed consistent findings of lower adverse maternal outcomes with the use of insulin detemir vs neutral protamine Hagedorn: for example, maternal hypoglycemic events (97% probability of benefit; posterior adjusted relative risk, 0.59; 95% credible interval, 0.29-1.08) and hypertensive disorders (88% probability of benefit; posterior adjusted relative risk, 0.81; 95% credible interval, 0.54-1.16). In our comparative effectiveness trial involving individuals with type 2 or overt type 2 diabetes mellitus, use of insulin detemir resulted in lower rates of adverse neonatal and maternal outcomes compared with neutral protamine Hagedorn.

Weight gain associated with insulin detemir vs insulin glargine in clinical practice: A retrospective longitudinal cohort study.

In comparative randomized studies, use of insulin detemir has been consistently demonstrated to be associated with less weight gain than the industry standard, insulin glargine. However, the magnitude of the relative reduction in weight gain with use of insulin determir vs insulin glargine in regulatory studies (reported values ranged from 0.77 kg to 3.6 kg) may not be generalizable to patients in real-world practice conditions. A study was conducted to substantiate detemir's purported weight-sparing advantage over insulin glargine in newly treated patients with type 2 diabetes mellitus under the conditions found in a clinical practice setting. A retrospective longitudinal cohort study design was applied in reviewing electronic medical records to identify insulin-naive, overweight patients with type 2 diabetes who received insulin detemir or insulin glargine therapy continued for up to 1 year. Patient weights at baseline and at each subsequent clinic visit after treatment initiation were identified. The primary outcome was the maximum weight increase from baseline after exposure to insulin detemir or glargine. The difference-in-differences (DiD) mean total body weight change was tested by analysis of covariance (ANCOVA). One hundred nine patient records (56 of patients who received insulin glargine and 53 of patients who received insulin detemir) met study criteria and underwent full abstraction. The covariate-adjusted estimated mean change in body weight associated with use of insulin detemir vs insulin glargine was -1.5 kg (95% CI, -2.89 to -0.12 kg; P = 0.04). The mean weight gain associated with detemir use was significantly less than the mean weight change observed with glargine use. The magnitude of weight change was consistent with that demonstrated in randomized controlled trials. These results further substantiate detemir's purported comparative weight-sparing properties under conditions found in a real-world practice setting.

Use of insulin detemir in dogs with diabetes mellitus

Insulin detemir is a long-acting basal insulin analogue recently introduced in veterinary medicine for treatment of canine diabetes mellitus. As there are only limited studies in dogs, long-term evaluation of insulin detemir in veterinary medicine is required. In this study, we investigated trends in12-hour blood glucose concentration during hospitalization and evaluated initial and following doses of insulin detemir for several months in six diabetic dogs. The mean levels of blood glucose over 12-hour periods were between 113.5 to 327.2 mg/dL, and the average glucose nadir was 103 mg/dL in the six dogs. The dogs were treated with a mean dosage of 0.24 U/kg of insulin detemir, but hypoglycemia was observed in four of the dogs at the first monthly follow-up. Thus, insulin doses were adjusted according to the nadir levels of glucose observed during the follow-up periods (range, 1 to 16 months). The total range of insulin doses throughout the study period was between 0.1 and 0.4 U/kg. Changes in insulin doses in each dog during the follow-up period were not variable. We suggest that insulin detemir might be not only an alternative choice against traditional insulin for patients with insulin resistance or concurrent disease but also an effective home therapy medication in canine patients with DM. This study could help inform veterinary practitioners regarding the use of insulin detemir for canine insulin-dependent DM.

Comparison of efficacy and safety of once- versus twice-daily insulin detemir added on to oral antidiabetics in insulin-naive type 2 diabetes patients: 24-week, crossover, treat to target trial in a single center

AimTo compare once- versus twice-daily insulin detemir added on OADS therapy in insulin-naive type 2 diabetes patients in terms of efficacy and safety. MethodsAn open-label study performed at a single center, comprised a randomized, crossover 24 week with insulin-naive type 2 diabetes patients. Insulin detemir was initiated with mean 0.12U/kg in all patients (Group I once-daily, Group II twice-daily) and titrated for 24 week. ResultsA total of 50 patients completed the study (Group I n:25, Group II n:25). With use of once- and twice-daily insulin, HbA1c values were decreased by 1.8% (±2.0) and 1.5% (±1.4) within the first 12 weeks (p<0.01), whereas increased by 0.21% (±0.7) and 0.14% (±0.8) in the second 12 weeks (p>0.05). The increases in the insulin doses were found as 0.22U/kg and 0.35U/kg with once- and twice-daily insulin use, respectively (p:0.04). Although minor hypoglycemic events were similar in both groups in the first 12 weeks, 2-fold increase was found in the patients shifting from once- to twice-daily dose. Within the first and second periods, the body weight of the patients was observed an increase of 0.4 and 1.6kg with once-daily dose, whereas a decrease of 0.1 and 2.1kg in the twice-daily dose, in the same period. ConclusionOnce-daily use of insulin detemir up to 0.4U/kg was found to have similar efficacy and safety as twice-daily use. Twice dose use of insulin did not provide a prominent glycemic control advantage on 1.5-fold higher use of insulin.

The Comparison of 24-Hour Urinary Sodium, Albumin, and Protein Excretion in Chronic Kidney Disease Patients with Type 2 Diabetes Mellitus Using Insulin Detemir or Insulin Glargine

Insulin detemir induces bodyweight loss or less weight gain in patients with type 2 diabetes mellitus. However, in contrast to insulin detemir, insulin glargine has no weight loss effect. Increased sodium excretion has been speculated to be one of the mechanisms of weight loss by insulin detemir. However, there are no studies in the literature comparing sodium excretion between patients using insulin detemir and those using insulin glargine. There are also no studies comparing the excretion of urinary albumin and urinary protein in chronic kidney disease (CKD) patients using insulin detemir or insulin glargine. Thus, the aim of the current study was to compare the effects of insulin detemir and insulin glargine on sodium, albumin, and protein excretion in patients with various stages of CKD and concomitant type 2 diabetes. Demographic, clinical, and laboratory data were evaluated for all patients. Hypoglycemic attacks, appetite score, 24-h urinary sodium, albumin, and protein excretion were also measured. A total of 47 patients (23 taking insulin detemir, 24 taking insulin glargine) were included in the study. There were no differences with respect to 24-h sodium (p = 0.694), albumin (p = 0.297), or protein excretion (p = 0.202) between patient groups. Appetite and hypoglycemic attacks also did not differ between groups. Use of insulin detemir or insulin glargine was not related to sodium, albumin, and protein excretion in stepwise regression analysis. There was no difference between insulin detemir and insulin glargine with respect to sodium, albumin, and protein excretion in type 2 diabetic CKD patients. Studies are needed both in CKD patients and those with normal renal function to highlight mechanisms regarding the weight loss effect unique to insulin detemir.

The use of insulin analogues in pregnancy

Excellent glycaemic control is essential in pregnancy to optimise maternal and foetal outcomes. The aim of this review is to assess the efficacy and safety of insulin analogues in pregnancy. Insulin lispro and insulin aspart are safe in pregnancy and may improve post-prandial glycaemic control in women with type 1 diabetes. However, a lack of data indicating improved foetal outcomes would suggest that there is no imperative to switch to a short-acting analogue where the woman's diabetes is well controlled with human insulin. There are no reports of the use of insulin glulisine in pregnancy and so its use cannot be recommended. Most studies of insulin glargine in pregnancy are small, retrospective and include women with pre-existing diabetes and gestational diabetes. There appear to be no major safety concerns and so it seems reasonable to continue insulin glargine if required to achieve excellent glycaemic control. A head-to-head comparison between insulin detemir and NPH insulin in women with type 1 diabetes showed that while foetal outcomes did not differ, fasting plasma glucose improved with insulin detemir without an increased incidence of hypoglycaemia. The greater evidence base supports the use of insulin detemir as the first line long-acting analogue in pregnancy but the lack of definitive foetal benefits means that there is no strong need to switch a woman who is well controlled on NPH insulin. There seems little justification in using long acting insulin analogues in women with gestational diabetes or type 2 diabetes where the risk of hypoglycaemia is low.

Insulin analogues dosing and costs - comparing real-life daily doses of insulin detemir and insulin glargine in type 2 diabetes patients

BackgroundThe uncertainties regarding dose similarities between basal long-acting insulin analogues remain. Recent real-world studies indicate dose similarities between insulin detemir and insulin glargine, but further studies are still warranted.The aim of this study was to compare real-life daily doses of insulin detemir and insulin glargine in type 2 diabetes patients when administered once daily.MethodsWe analysed 536 patient cases from general practice (63%) and endocrinological outpatient clinics (37%). A self-administered questionnaire completed by the treating physician was used to obtain data on patient characteristics (gender, age, weight, height, latest HbA1c-value), daily doses, administration of and number of years treated with insulin detemir and insulin glargine, concomitant insulin use and use of non-insulin anti-diabetic medication. Both bivariate analyses and multivariate regression analyses were applied to examine whether there were differences in the daily doses of insulin detemir and insulin glargine.ResultsThere was no significant difference in the mean daily doses of insulin detemir (0.414 U/kg) and insulin glargine (0.416 U/kg) (p = 0.4341). In multivariate regression analyses, age and BMI had a significant influence on daily insulin dose with the dose increasing 0.003 U/kg (p = 0.0375) and 0.008 U/kg (p = 0.0003) with every 1 increment in age and BMI, respectively.ConclusionsDose similarities between insulin detemir and insulin glargine were seen in type 2 diabetes patients when administered once daily. Thus, the use of insulin detemir and insulin glargine is not associated with different medical costs if the price and treating algorithm are similar.

In response to Pantalone et al. Use of insulin detemir and insulin glargine during pregnancy: Are the Data convincing?

In response to Pantalone et al. Use of insulin detemir and insulin glargine during pregnancy: Are the Data convincing?

Iowa medicaid 2: lapse of glycemic control on abrupt transition from insulin glargine to insulin detemir in type 2 diabetes mellitus

Background: Iowa Care (Iowa Medicaid in State of Iowa, USA), switched insulin glargine to detemir in subjects with Diabetes Mellitus (DM) without the knowledge or approval of healthcare providers beginning 8/2006.Impact of this transition in subjects with Type 1 DM is recently reported. Objective: To examine the impact of this transition on various parameters of diabetes management in Type 2 DM. Subjects and Methods: A retrospective review of the records of subjects with Type 2 DM was conducted until 8/2007 in whom the transition had occurred. Only those subjects with adequate glycemic control while receiving insulin glargine [GI] and completing at least 3 months of therapy with insulin detemir [DI] are included in this report. Ten subjects with Type 2 DM, duration 7 ± 2 years with age, 55 ± 3 years who were switched from GI to DI (Group 1) fulfilled the criteria for inclusion. Subjects were switched from GI in Q AM to DI Q HS in the same daily dose. Glycemic control (HbA1c), body weight, daily insulin dose (Units) and severe hypoglycemic events during the last 2 weeks of the period, pre switch and again at the end of 3 months post switch were assessed. Records of 8 subjects matched for age, duration of DM, glycemic control while receiving GI for additional 3 months (Group 2) during the same period were examined for comparison. All subjects were followed in the outpatient clinic at intervals of 3 months. Results Glycemic control remained stable on continuing GI AM; HbA1c; 7.1 ± 0.3 to 7.1 ± 0.3%, while it worsened on switching to DI Q HS; HbA1c, 7.1 ± 0.3 to 8.1 ± 0.5 [P < 0.01]. A mild weight loss was noted in subjects on transition. No severe hypoglycemic events were reported in any subject in either group. Conclusion Abrupt transition from insulin glargine to insulin detemir in subjects with Type 2 DM is likely to result in lapse of glycemic control which may cause decreased quality of life. Furthermore, use of insulin detemir may result in increased costs due to need of the higher daily dose as well as additional equipment required for probable twice daily administration to achieve adequate glycemic control. Therefore, insulin glargine and detemir appear to be far from being bioequivalent.

PDB11 DRUG-USE PATTERNS OF INITIALLY PRESCRIBED INSULIN DETEMIR AND INSULIN GLARGINE IN THE NETHERLANDS;A COMPARATIVE ANALYSIS USING PHARMACY DATA FROM IADB. NL

OBJECTIVES: Newer long-acting insulin analogs have shown to result in several treatment improvements if compared with NPH insulins. Promising results from clinical trials require confirmation from observational settings reflecting potential “real-life” benefits. Therefore, the current study aimed to evaluate trends in prescribing (uptake), treatment adherence, and costs of (newer) insulin analogs (e.g., insulin detemir and insulin glargine). METHODS: A drug-utilization analysis was conducted based on using daily- practice prescription data from IADB.nl (one of the databases available in the Mondri- aan infrastructure), a dispensing database of 50 pharmacies, covering a Dutch population of 500,000. Drug-utilization data were collected for a 7-year period (2000-2007). All patients that received at least one prescription of an insulin analog-defined following the “Anatomical Therapeutical Classification” (ATC) as “A10A”-were included for this study. The prevalence and incidence of insulin use were both presented per 1000 population. Survival analysis was conducted to calculate the persistence on different insulin analogs. RESULTS: Preliminary results show a fast increase in the proportion of patients using the newer long-acting insulin analogs with 7% in 2003 to over 30% in 2006. Among patients initiating these newer insulin analogs, use of insulin glargine is more than two times higher compared to use of insulin detemir (507 vs. 190 starters in 2006). Patients that initiated treatment with long-acting insulin analogs were significantly more adherent to insulin glargine compared to insulin detemir (exact figures will be presented during the presentation). CONCLUSIONS: Current preliminary results show an increase in use of long-acting insulin analogs. Of these analogs, insulin glargine is most often initiated and seems to be well-received by patients. Further results will be presented based on a longer follow-up period including differences in HbAlc level dependent dosing and trends in cost development for insulin analogs over time. Also, the potential feature of “channelling” will be investigated.

Time-action profiles of insulin detemir in normal and diabetic dogs

Insulin detemir is the first member of a new class of long-acting soluble insulin analogues capable of maintaining the basal level of insulin in humans. In this preliminary study, we investigated the time-action profiles of insulin detemir in normal and diabetic dogs since the use of insulin detemir in canines has yet to be determined. Eight animals were used in our study (three normal and five insulin dependent diabetic dogs). Time-action profiles of insulin detemir were monitored in normal dogs using an artificial pancreas apparatus under euglycemic condition. Blood sampling was performed at 2 h intervals post feeding, with insulin administration, in insulin dependent diabetic dogs. Time-action profiles of insulin detemir, in normal dogs, demonstrated that insulin detemir is a long-lasting preparation similar to what has been observed in humans. A pronounced peak was detected at 8–10 h while the glucose-lowering effect lasted for over 24 h after insulin injection, thus illustrating its longer prolonged peak activity time. Furthermore, intensive glycemic control was achieved with insulin detemir in insulin dependent diabetic dogs, using a lower dosage than NPH insulin and insulin glargine therapeutic doses. Our results indicate that insulin detemir has a greater effect than either NPH insulin or insulin glargine in canines, requiring a lower dose than either insulin preparation. However, using insulin detemir also carries a higher risk of inducing hypoglycemia as compared to either NPH insulin or insulin glargine.

Critical appraisal of the safety and efficacy of insulin detemir in glycemic control and cardiovascular risk management in diabetics

Critical appraisal of the safety and efficacy of insulin detemir in glycemic control and cardiovascular risk management in diabetics Jean-Pierre Le FlochDepartment of Diabetology, Medical Clinic, Villecresnes, FranceAbstract: Insulin detemir is an analog of human insulin designed to provide a long duration of basal insulin action. This is achieved by protracted absorption from the injection depot, which results in part from increased self-association of insulin detemir molecules and in part from reversible albumin binding. Subsequent albumin binding in the circulation is thought to buffer changes in the effects at target tissues that could otherwise arise from variability in absorption rate. In consequence, insulin detemir has shown a less variable pharmacodynamic profile than alternative basal insulins; this manifests as more consistent temporal glucose reduction profiles in repeat-clamp studies. In clinical trials, insulin detemir has been characterized by consistent risk reductions in hypoglycemia, as well as reduced weight gain in comparison with other basal insulins. Given some recent associations that have been made in prospective and epidemiologic studies between glucose variability and/or hypoglycemia and increased cardiovascular risk, and the long-known association between excess weight and cardiovascular risk, it is possible that the clinical profile of insulin detemir may carry prognostic value with regard to cardiovascular safety, although this is yet to be substantiated. There have also been some concerns raised recently over the use of insulin analogs and cancer risk, but available clinical data and the receptor interaction profile of insulin detemir suggest no excess in risk in comparison with human insulin therapy. Optimal approaches for the clinical use of insulin detemir have been emerging through an increasing clinical study base, and the analog is becoming established as a potentially valuable therapy option.Keywords: insulin detemir, type 2 diabetes, glucose variability, hypoglycemia, weight gain

Critical appraisal of the safety and efficacy of insulin detemir in glycemic control and cardiovascular risk management in diabetics

Insulin detemir is an analog of human insulin designed to provide a long duration of basal insulin action. This is achieved by protracted absorption from the injection depot, which results in part from increased self-association of insulin detemir molecules and in part from reversible albumin binding. Subsequent albumin binding in the circulation is thought to buffer changes in the effects at target tissues that could otherwise arise from variability in absorption rate. In consequence, insulin detemir has shown a less variable pharmacodynamic profile than alternative basal insulins; this manifests as more consistent temporal glucose reduction profiles in repeat-clamp studies. In clinical trials, insulin detemir has been characterized by consistent risk reductions in hypoglycemia, as well as reduced weight gain in comparison with other basal insulins. Given some recent associations that have been made in prospective and epidemiologic studies between glucose variability and/or hypoglycemia and increased cardiovascular risk, and the long-known association between excess weight and cardiovascular risk, it is possible that the clinical profile of insulin detemir may carry prognostic value with regard to cardiovascular safety, although this is yet to be substantiated. There have also been some concerns raised recently over the use of insulin analogs and cancer risk, but available clinical data and the receptor interaction profile of insulin detemir suggest no excess in risk in comparison with human insulin therapy. Optimal approaches for the clinical use of insulin detemir have been emerging through an increasing clinical study base, and the analog is becoming established as a potentially valuable therapy option.

Comparison of one-year costs of Type 2 diabetes treatment with insulin glargine or insulin detemir in a basal supported oral therapy (BOT) in Germany

A one-year cost analysis comparing basal insulin analogues glargine (IG, Lantus) versus detemir (ID, Levemir) in combination with oral antidiabetic drugs (basal supported oral therapy; BOT) in insulin naive Type 2 diabetes patients in Germany based on the results of a randomized controlled clinical trial (RCT). The trial demonstrated equivalent treatment efficacy. Total direct diabetes treatment costs were estimated from the perspective of the German statutory health insurance (SHI) for the time horizon of one-year. Simulated resources included medication (insulin, oral antidiabetic drugs) and consumable items (needles, blood glucose test strips and lancets). Initial and final insulin doses per kg body weight and proportion of patients with once/twice daily insulin injection were taken from the above mentioned RCT. Unit costs were taken from official German price lists and sources. Deterministic-(DTA) and probabilistic sensitivity analyses (PSA) on resource use and unit costs were performed to test robustness of the results. Average annual treatment costs per patient (base case) were euro 849 for glargine and euro 1,334 for detemir resulting in cost savings of euro 486 per patient per year (36%). Costs of insulins were euro 469 (IG) and euro 746 (ID). Costs of consumable items amounted at euro 380 (IG) and euro 588 (ID) respectively. Sensitivity analyses confirmed the findings in favor of insulin glargine. PSA results found cost savings ranging from euro 429 to euro 608 (5th/95th percentiles). The current model estimated that insulin glargine was associated with lower annual treatment costs of euro 486 (36%) compared to the use of insulin detemir while the same glycemic control is expected to be achieved.

Use of insulin detemir in pregnancy: a report on 10 Type 1 diabetic women

Use of insulin detemir in pregnancy: a report on 10 Type 1 diabetic women

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

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.

An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update)

Background: The efficacy and tolerability of insulin detemir (detemir), a long-acting basal insulin analog, is already well documented for type 1 diabetes. This article reviews new evidence, in particular on the weight-sparing effect of detemir and its use in type 2 diabetes. Methods: All clinical trials of detemir published since a 2006 drug evaluation and up to December 2007, including large real-life studies, are covered in this review. Earlier studies are cited when relevant. Results/conclusion: In type 2 diabetes, detemir used once or twice daily achieves equivalent glycemic control to other basal insulins in treat-to-target trials but tends to improve control in patients switched from other basal insulins in basal–oral regimens. The risk of hypoglycemia (nocturnal, overall, or both) is substantially and significantly reduced with detemir compared with NPH insulin. Body weight increase is consistently significantly lower with detemir than with NPH in type 1 and type 2 diabetes. The results of both glucose clamp studies and clinical trials support initiation of detemir at a once-daily dosing regimen.

Improved glycemic control and lower frequency of severe hypoglycemia with insulin detemir; long-term experience in 105 children and adolescents with type 1 diabetes

To assess the effect of the insulin analog detemir on glycemic control and severe hypoglycemia in children and adolescents with type 1 diabetes. A retrospective chart analysis was performed in 105 patients with type 1 diabetes after switching to insulin detemir between 2004 and 2007. In children below 12 yr of age (n = 53), evening neutral protomin hagedorn (NPH) insulin was replaced by insulin detemir if therapeutic goals were not reached and blood glucose levels were unpredictable or hardly controllable. In adolescents above 12 yr of age (n = 52), insulin detemir was started when changing to intensified insulin therapy. In children below 12 yr of age, hemoglobin A1c (HbA1c) at start was 8.3 +/- 0.8% and after 12 months of treatment with insulin detemir significantly lowered (7.6 +/- 0.6%, p < 0.001). In the age-group above 12 yr of age at the start of the study, the improvement of HbA1c after 12 months of treatment was less pronounced (8.0 +/- 1.2 vs. 7.6 +/- 1.0%) but still significant (p < 0.01). The risk for severe hypoglycemia was significantly decreased compared with patients attending the outpatient clinic between 1995 and 2003 (4.8/100 patient years vs. 7.6/100 patient years, p = 0.003). From the beginning to the end of the follow-up period, body mass index dropped significantly in children below 12 yr of age but no effect was observed in adolescents. Use of insulin detemir allows a safe nocturnal glycemic control in children and adolescents with type 1 diabetes and is associated with significantly improved HbA1c levels and fewer severe hypoglycemic events. This makes insulin detemir a most valuable new tool for the treatment of children and adolescents with type 1 diabetes.