LEVEMIR SUMMARY
PATIENT INFORMATION
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)
Short-term effects of the long-acting insulin analog detemir and human insulin on plasma levels of insulin-like growth factor-I and its binding proteins in humans. [2009.08]
CONCLUSIONS: The greater plasma insulin concentrations obtained with IDet exert effects on plasma levels of IGF-I, IGFBP-1, and IGFBP-3 similar to those of HI. Additional studies are needed to confirm these short-term results in patients with diabetes mellitus on long-term treatment with IDet.
Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial. [2009.04]
BACKGROUND: Patients with type 2 diabetes (T2DM) have an increased mortality rate primarily because of macrovascular disease. Where T2DM patients cannot be managed sufficiently through diet, exercise and peroral antidiabetic drugs, that is when haemoglobin A1c (HbA1c) is above 7.0%, it is yet unknown whether a combination of metformin and insulin analogues is superior to insulin analogues alone. Nor is it known which insulin analogue regimen is the optimal. OBJECTIVE: The primary objective of this trial is to evaluate the effect of an 18-month treatment with metformin vs. placebo in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients... CONCLUSION: CIMT is designed to provide evidence as to whether metformin is advantageous even during insulin treatment and to provide evidence regarding which insulin analogue regimen is most advantageous with regard to cardiovascular disease.
Comparison of Inpatient Insulin Regimens with Detemir plus Aspart Versus Neutral Protamine Hagedorn plus Regular in Medical Patients with Type 2 Diabetes. [2009.02]
Background: Studies comparing the use of basal bolus with insulin analogs vs. split-mixed regimens with human insulins in hospitalized patients with type 2 diabetes are lacking... Conclusions: Treatment with basal/bolus regimen with detemir once daily and aspart before meals results in equivalent glycemic control and no differences in the frequency of hypoglycemia compared to a split-mixed regimen of NPH and regular insulin in patients with type 2 diabetes.
Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. [2009.01]
AIMS: Insulin analogues are widely used but few data exist comparing different analogue regimens. We compared two such regimens in type 2 diabetes mellitus (T2DM) uncontrolled by oral antidiabetic agents (OADs) with or without basal insulin... CONCLUSIONS: Modern insulin analogue regimens, adjusted to PG targets, enable a majority of people with T2DM to reach HbA(1c)< or =7.0% after failure of OADs and OAD-basal insulin therapy. Insulin-treated patients may benefit more from transfer to analogue basal-bolus therapy, while insulin-naive individuals benefit equally well from the more convenient biphasic analogue regimen.
Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. [2008.12]
Insulin detemir (detemir) has previously been shown to be associated with lower within-subject variability compared with other basal insulin preparations in adults with type 1 diabetes mellitus (T1DM). This randomized, double-blind, crossover trial compared the within-subject variability of detemir and insulin glargine (glargine) in pharmacokinetic properties in children and adolescents with T1DM...
Clinical Trials Related to Levemir (Insulin Detemir Subcutaneous)
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-Life" Usage in Germany [Recruiting]
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe..
The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate
treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in
daily settings.
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus [Recruiting]
This study is conducted in Asia.
The aim of this observational study is to evaluate the safety and tolerability of Levemir™
FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2
Diabetes Mellitus.
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia [Recruiting]
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.
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus [Recruiting]
Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics [Recruiting]
This study is conducted in Europe.
Observational study evaluating the body weight progress during the treatment with insulin
detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins
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