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Levemir (Insulin Detemir Subcutaneous) - Summary

 
 



LEVEMIR SUMMARY

LEVEMIR® (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analog, with up to 24 hours duration of action, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29.

LEVEMIR is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.


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NEWS HIGHLIGHTS

Published Studies Related to Levemir (Insulin Detemir Subcutaneous)

Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial. [2011.11.08]
ABSTRACT: BACKGROUND: Children with type 1 diabetes (DM1) often use three daily (TID) injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA) at dinner in a twice daily (BID) injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at dinner (intervention) to those using a standard TID regimen (control) over 6 months... CONCLUSIONS: In this pilot study, incorporating LAIA in a BID regimen did not cause deterioration in HbA1c or increases in adverse events; suggesting that this may be a viable option for families where a more simplified insulin regimen would be beneficial and compliance may be improved. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00522210.

Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. [2011.09.01]
OBJECTIVE: To compare the efficacy and safety of 2 intensification strategies for stepwise addition of prandial insulin aspart in patients with type 2 diabetes mellitus treated with insulin detemir... CONCLUSION: The SimpleSTEP and ExtraSTEP strategies for stepwise addition of insulin aspart to 1 or more meals were equally effective at intensifying therapy in patients with type 2 diabetes not achieving glycemic control on basal insulin and oral antidiabetic drugs.

Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. [2011.09]
As basal insulin analogues are being used off-label, there is a need to evaluate their safety (maternal hypoglycaemia and fetal and perinatal outcomes) and efficacy [haemoglobin A1c(HbA1c), fasting plasma glucose, and maternal weight gain]. The aim of this review is to provide an overview of the current literature concerning basal insulin analogue use in diabetic pregnancy, and to present the design and preliminary, non-validated baseline characteristics of a currently ongoing randomized, controlled, open-label, multicentre, multinational trial comparing insulin detemir with neutral protamine hagedorn insulin, both with insulin aspart, in women with type 1 diabetes planning a pregnancy (n = 306) or are already pregnant (n = 164).

Optimized glycaemic control achieved with add-on basal insulin therapy improves indexes of endothelial damage and regeneration in type 2 diabetic patients with macroangiopathy: a randomized crossover trial comparing detemir versus glargine. [2011.08]
AIMS: In diabetes, endothelial damage promotes macroangiopathy and endothelial regeneration is impaired, owing to reduced endothelial progenitor cells (EPCs). Given that insulin influences endothelial biology, we compared the effects of add-on basal insulin analogues on endothelial damage and regeneration in type 2 diabetes (T2D)... CONCLUSION: Optimized glycaemic control by add-on basal insulin improved indexes of endothelial damage and regeneration. Compared to glargine, detemir achieved similar endothelial protection with lower weight gain and less hypoglycaemia. These results might have implications for therapy of aging T2D patients with cardiovascular disease. (c) 2011 Blackwell Publishing Ltd.

Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. [2011.07]
CONCLUSIONS: The reduced weight gain with insulin detemir compared with NPH insulin is attributed to reduced energy intake rather than increased energy expenditure. This may be mediated by a direct or indirect effect of insulin detemir on the hormones that control satiety.

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Clinical Trials Related to Levemir (Insulin Detemir Subcutaneous)

The Effects of Insulin Detemir and Gliclazide-MR Treatments on Endothelial Functions in Patients With Type 2 Diabetes [Completed]
The main purpose of this study is to analyze the effects of the addition of sulfonylurea (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial cell functions. The second goal is to identify the effects of these treatment alternatives on body-mass index, the changes in body fat mass, insulin resistance and on the insulin secretion capacity of beta cells. The third aim of this study is to determine the success rates of these treatment alternatives on glycemic control at 6 months follow-up.

Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir� [Completed]
This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e. g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania

Observational Study to Observe the Efficacy of Levemir� (Insulin Detemir) in Patients With Type 2 Diabetes. [Completed]
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes [Completed]
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (or NAFLD, a common condition in T2DM; Cusi K, Current Diabetes Reports 2009) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study was to determine the effect on hepatic steatosis and insulin secretion/action of lowering the fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2 diabetes mellitus (T2DM). In the first 3 months the investigators will optimize metabolic control in all patients with intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After this treatment period, patients will be randomized in the second 3 months in a 2: 1 ratio to insulin detemir or detemir plus aspart. The investigators propose that insulin will improve day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and insulin secretion/sensitivity being well tolerated while causing minimal weight gain and hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.

Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia [Completed]
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

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Reports of Suspected Levemir (Insulin Detemir Subcutaneous) Side Effects

Blood Glucose Increased (62)Hypoglycaemia (21)Blood Glucose Decreased (17)Dyspnoea (12)Maternal Exposure During Pregnancy (12)Drug Ineffective (10)Dizziness (10)Diabetes Mellitus Inadequate Control (10)Dehydration (10)Rash (9)more >>


Page last updated: 2011-12-09

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