Type 2 diabetes insulin regimen calculation,how to eat for type 2 diabetes,the diabetes miracle cure book cooperstown,diabetes type 2 alternative treatment - New On 2016

Intensive therapy to achieve glycemic target has become the standard of care in management of patients with type 2 diabetes mellitus (DM). The last two decades have seen an explosive increase in the number of people with diabetes globally due to changes in lifestyle and genetic predisposition 1,2 Patients with diabetes mellitus have an impaired capacity to regulate blood glucose. The percentage of glycated haemoglobin type A1c (% HbA1c) represents a 2a€“3 month average of overall blood glucose control, which is a reflection of both fasting and prandial blood glucose. The aim of this review is to consider the evidence for the premix analogue insulin, biphasic insulin aspart 30 (BIAsp 30, NovoMixA® 30, Novo Nordisk), as a viable treatment option when initiating insulin in patients with type 2 diabetes. Insulin injections are the standard treatment for type 1 diabetes, and often need to be initiated in the later stages of type 2 diabetes.
The relative contributions of fasting and postprandial blood glucose to HbA1c and the associated risks have been much studied and debated.
The role of postprandial BG as an independent contributor to diabetes complications and the need to target it for prevention of cardiovascular events are a matter of intense debate.In Diabetes Intervention Study (DIS), plasma glucose after breakfast, but not fasting plasma glucose, has been found to predict myocardial infarction and mortality in newly diagnosed type 2 diabetic patients15.
To mimic the a€?normala€™ prandial release of insulin and control blood glucose excursions, short-acting insulin injected subcutaneously must be absorbed quickly. In recent years, analogues of human insulin have been developed by introducing small changes to the amino acid sequence that alter the kinetic profile of the insulin, while retaining its metabolic actions.22 One of these analogues, insulin aspart, has aspartic acid inserted at position B28 in place of the usual proline (Fig 1). The development of insulin aspart has been followed by the addition of a novel premix analogue insulin: dual-release or a€?biphasica€™ insulin aspart (BIAsp 30, NovoMixA® 30, Novo Nordisk). When combined with protamine-crystallised insulin aspart in BIAsp 30, insulin aspart retains its pharmacological profiles.25 This has been demonstrated in several studies comparing the pharmacokinetic and pharmacodynamic properties of BIAsp 30 with those of biphasic human insulin (BHI 30, consisting of 30% soluble human insulin and 70% neutral protamine Hagedorn), intermediate-acting insulin and other insulin analogues (Table 1). Boehm et al compared postprandial and overall glycemic control in a population of patients with type I or type II diabetes (n=294) treated with BIAsp 30 or human insulin 30 in a randomised, open label parallel group study.
Raskin et al.33 compared twice-daily BIAsp 30 with once-daily IGlarg in insulin-naA?ve patients with type 2 diabetes who were poorly controlled on OADs (only continuation with pioglitazone was allowed during the treatment phase).
The first insulin treatment for patients with type 2 diabetes is often a basal insulin in a once- or twice-daily regimen, initially in combination with an OAD. In this 48-week, open-label trial of 100 type 2 patients poorly controlled on OADs (with or without once-daily basal insulin), all patients were started on once-daily BIAsp 30 before dinner (phase 1). Bebakar et al 200741, randomised 192 type 2 diabetic patients in a 2 : 1 ratio either to receive BIAsp30 or OAD only. Therefore, it may be appropriate to commence with one injection at dinnertime (or the largest meal) and add additional injections i.e intensify therapy to twice and thrice daily35-38, if patient has not achieved the target blood glucose control. To reduce the risk of long-term complications of diabetes such as neuropathy, retinopathy and atherosclerosis, blood glucose must be tightly controlled.7,9,10 However, there has to be a balance between achieving good glycaemic control and avoiding hypoglycaemia. Increasing the dosing frequency of BIAsp 30 does not necessarily lead to a greater risk of hypoglycaemia36 . A largest clinical experience observational study (PRESENT) with BIAsp 30 was done to provide complementary data to support the clinical trial data already existing on BIAsp 30 treatment in type 2 diabetes. A user-friendly insulin delivery system may improve patient compliance, and consequently improve glycaemic control.48 It is important, therefore, to ensure that the delivery system is simple, easy to operate and discreet. Patients generally prefer a pen-type delivery device to the conventional vial and syringe, for improved quality of life.48a€“51 BIAsp 30 uses the FlexPenA® delivery system, which incorporates a number of features designed to maximise user confidence, such as an audible a€?clicka€™ when dialling-up the dose.
Insulin analogues are chemically modified to alter their pharmacokinetic profiles, without compromising their metabolic actions. This better glycemic control has been achieved with significantly less number of hypoglycaemic events (both major and nocturnal) in comparison to other regimens, which have not increased despite intensification with BIAsp 30.
Wright A, Felix Burden AC, Paisey RB, Cull CA, Holman RR, for the UK Prospective Diabetes Study Group. At Sanofi Diabetes, our priorities are focussed on the needs of people with diabetes around the world. We want people to live 'beyond' diabetes, to achieve aspirations and to make the most of everyday!
Use upper body and lower body exercises that are basic in design (chest presses, lat pulldowns, knee bend exercise for legs such as leg press, squats, leg extension and leg curls). Ramsey Rodriguez is a Sports Fitness Consultant with 25 years of professional experience in fitness training, sports nutrition and natural alternatives for health and wellness. Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. LEVEMIR(insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as an injection. Figure 2 shows glucose infusion rate results from a 16-hour glucose clamp study in patients with type 2 diabetes. Children and Adolescents- The pharmacokinetic properties of LEVEMIR were investigated in children (6 to 12 years) and adolescents (13 to 17 years) and adults with type 1 diabetes. Geriatrics- In a clinical trial investigating differences in pharmacokinetics of a single subcutaneous dose of LEVEMIR in young (25 to 35 years) versus elderly (a‰?68 years) healthy subjects, higher insulin AUC levels (up to 35%) were found in elderly subjects due to a reduced clearance.
Gender- In controlled clinical trials, no clinically relevant difference between genders is seen in pharmacokinetic parameters based on subgroup analyses. Race- In two trials in healthy Japanese and Caucasian subjects, there were no clinically relevant differences seen in pharmacokinetic parameters. Renal impairment- Individuals with renal impairment showed no difference in pharmacokinetic parameters as compared to healthy volunteers. Hepatic impairment- Individuals with severe hepatic dysfunction, without diabetes, were observed to have lower AUCs as compared to healthy volunteers. Pregnancy- The effect of pregnancy on the pharmacokinetics and pharmacodynamics of LEVEMIR has not been studied (see PRECAUTIONS, Pregnancy ). Smoking- The effect of smoking on the pharmacokinetics and pharmacodynamics of LEVEMIR has not been studied.The efficacy and safety of LEVEMIR given once-daily at bedtime or twice-daily (before breakfast and at bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH human insulin or once-daily insulin glargine in non-blinded, randomized, parallel studies of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In one non-blinded clinical study (Study A, n=409), adult patients with type 1 diabetes were randomized to treatment with either LEVEMIR at 12-hour intervals, LEVEMIR morning and bedtime or NPH human insulin morning and bedtime.
In a non-blinded, randomized, controlled clinical study (Study D, n=347), pediatric patients (age range 6 to 17) with type 1 diabetes were treated for 26 weeks with a basal-bolus insulin regimen. In a 24-week, non-blinded, randomized, clinical study (Study E, n=476), LEVEMIR administered twice-daily (before breakfast and evening) was compared to a similar regimen of NPH human insulin as part of a regimen of combination therapy with one or two of the following oral antidiabetes agents (metformin, insulin secretagogue, or I±a€“glucosidase inhibitor). 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.LEVEMIR is contraindicated in patients hypersensitive to insulin detemir or one of its excipients. Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis.
In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, LEVEMIR was associated with somewhat less weight gain than NPH (Table 4). Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. After each injection, patients must remove the needle without recapping and dispose of it in a puncture-resistant container. Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. This approach has been predicted to reduce the occurrence of long term diabetic complication and can be achieved only with early and aggressive use of insulin.
In type 1 diabetes, autoimmune destruction of pancreatic beta cells results in a diminished and rapidly absent ability to produce insulin. However, many treatment options exist for patients with type 2 DM, including dietary changes, physical activity, oral antidiabetic drugs (OADs) and the new injectable medications (eg, pramlintide, exenatide). Basal bolus therapy with multiple daily injections or an insulin pump is the most physiological approach to insulin replacement therapy. During the early stages of type 2 diabetes, the first-line treatment comprises altered diet and exercise, although oral antidiabetic drugs (OADs) are usually soon required to stimulate pancreatic insulin secretion (e.g.
The DECODE Study Group, by analyzing both fasting and postchallenge glucose concentrations from 14 prospective European cohorts also found the strong correlation between cardiovascular mortality and post prandial glycemia16. This combines rapid-acting soluble insulin aspart (30%), which addresses prandial insulin needs, with protamine-crystallised insulin aspart (70%), which has a delayed action of intermediate duration, for between meal and nocturnal insulin requirements. The study was initially planned for 12 weeks then serially extended for one, two and four years.31,34 The HbA1c-lowering effect of BIAsp 30 is equal to that of BHI 30 (twice-daily in patients with type 1 or type 2 diabetes) but treatment with BIAsp 30 resulted in a more favourable degree of postprandial blood glucose control than BHI 30. In type 1 patients37 significant improvement in long term glycemic control was found, without increasing the risk of hypoglycaemia and there was minimum inter day variation in BIAsp 30 pharmacokinetics.
Patients switched to 2 or 3 daily injections after 3, 6 or 9 months if targetglycaemic goals were not reached. This can enable patients to be managed with single premixed insulin analogue throughout the course of their disease.
In a recent study, 308 insulin-naA?ve type 2 patients poorly controlled on OADs were randomised to BIAsp 30 thrice-daily, BIAsp 30 twice-daily plus metformin, or optimised OAD therapy.

This was a 6-month, prospective, multinational, multiethnic observational study involving 21,977 patients from 13 countries.
However, efficacy is not significantly reduced when the injection time is delayed relative to the start of a meal.46 When administered immediately before a meal, BIAsp 30 produces a lower 5-h postprandial serum glucose profile (AUCsg) than that of BHI 30 when given either 15 minutes before or immediately before a meal. Responses showed the FlexPenA® to be superior for ease of use, utility and convenience, and confidence in optimal diabetes management.
BIAsp 30, a premix insulin analogue is a simple regimen for insulin initiation in patients with type 2 diabetes.
Its availability in the patient-friendly FlexPenA® and meal time flexibility adds to the convenience of the patient resulting in better compliance to regimen.
A glimpse of the a€?natural historya€™ of established type 2 (non-insulin dependent) diabetes mellitus from the spectrum of metabolic and hormonal responses to a mixed meal at the time of diagnosis.
High blood glucose concentration is a risk factor for mortality in middle-aged nondiabetic men.
Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria.
The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57). United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c).
Risk factors for myocardial infarction and death in newly detected NIDDM: the diabetes intervention study, 11-year follow-up.
Comparative pharmacokinetics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers.
Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Postprandial glycemic control with biphasic insulin aspart in patients with type 1 diabetes. Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes.
Twice-daily biphasic insulin aspart 30 vs biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes. Multiple mealtime administration of biphasic insulin aspart 30 versus traditional basal-bolus human insulin treatment in patients with type 1 diabetes.
Biphasic Insulin Aspart Given Thrice Daily is as Efficacious as a Basal-Bolus Insulin Regimen with Four Daily Injections A Randomised Open-Label Parallel Group Four Months Comparison in Patients with Type 2 Diabetes. Effect of BIAsp30 in combination with oral hypoglycaemic agents on glycemic control in nonobese patients with type 2 diabetes mellitus.
Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes Diabetes Obes Metab.
Insulin treated patients with type 2 diabetes mellitus have higher rates of nocturnal than day time hypoglycaemia: continuous blood glucose monitoring (CBGM) run-in data from the REACH study. Patients with type 2 diabetes mellitus have lower rates of nocturnal hypoglycaemia on biphasic insulin aspart (BIAsp 30) than on biphasic human insulin-30 (BHI30): data from the REACH study.
Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study.
Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study.
Postprandial versus preprandial dosing of biphasic insulin aspart in elderly type 2 diabetes patients. Insulin-pen treatment, quality of life and metabolic control: retrospective intra-group evaluations. Comparative evaluation of FlexPena„?, a new prefilled insulin delivery system, among patients and healthcare professionals. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Jack Wilmore, a highly esteemed and legendary figure in Exercise Physiology and co-founder of the Huffines Institute at Texas A&M University in Texas stated years ago that muscle tissue is very active tissue and can burn 30-40 calories per pound of muscle at rest. 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.
It has the following structure:LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Similar to NPH human insulin, slightly higher plasma Area Under the Curve (AUC) and C were observed in children by 10% and 24%, respectively, compared to adolescents and adults. As with other insulin preparations, LEVEMIR should always be titrated according to individual requirements.
Pharmacokinetics and pharmacodynamics of LEVEMIR were investigated in a clamp trial comparing patients with type 2 diabetes of Caucasian, African-American, and Latino origin. However, literature reports have shown that clearance of human insulin is decreased in renally impaired patients.
Careful glucose monitoring and dose adjustments of insulin, including LEVEMIR, may be necessary in patients with hepatic dysfunction (see PRECAUTIONS, Hepatic Impairment). In general, patients treated with LEVEMIR achieved levels of glycemic control similar to those treated with NPH human insulin or insulin glargine, as measured by glycosylated hemoglobin (HbA).
LEVEMIR and NPH human insulin were administered once- or twice-daily (bedtime or morning and bedtime) according to pretrial dose regimen.
LEVEMIR and NPH similarly lowered HbA from baseline (Table 3).In a 22-week, non-blinded, randomized, clinical study (Study F, n=395) in adults with Type 2 diabetes, LEVEMIR and NPH human insulin were given once- or twice-daily as part of a basal-bolus regimen. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations.
The first symptoms of hyperglycemia usually occur gradually over a period of hours or days. Mild injection site reactions occurred more frequently with LEVEMIR than with NPH human insulin and usually resolved in a few days to a few weeks (see PRECAUTIONS, Allergy).
Used syringes, needles, or lancets should be placed in a€?sharpsa€? containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). In-use cartridges and prefilled syringes in-use must NOT be stored in a refrigerator and must NOT be stored with the needle in place. The most acceptable choice will be a regimen which mimics physiologic pattern of insulin secretion from healthy pancreatic I?-cells. With type 2 diabetes, the disease is progressive, typically starting with peripheral insulin resistance. UKPDS 57 has shown that majority of patients with type II diabetes mellitus also eventually require insulin11. However, regimen complexity, patient preference, and other practical factors may dictate the treatment option chosen. Also Cavalot et al 2006, in 529 type 2 diabetic patients concluded that postprandial, but not fasting, blood glucose is an independent risk factor for cardiovascular events in type 2 diabetes, with a stronger predictive power in women than in men, suggesting that more attention should be paid to postprandial hyperglycemia, particularly in women17.
After completion of 3 month trial, the study patients with type 2 diabetes (n=125) were allowed to continue treatment in an open a€“ label fashion for an additional 21 months. The patients were either insulin-naA?ve or previously treated with insulin glargine or NPH.35 Furthermore, for patients who do not reach HbA1c targets on once- or twice-daily BIAsp 30, intensification to thrice-daily administration has been shown to be effective 35,36. After 16 weeks of therapy, those patients that had not attained an HbA1c a‰¤6.5% had their dosing frequency increased to twice-daily (phase 2). Once daily start with a premix insulin is simple and better as it takes care of both prandial and basal insulin requirements.
Although improvement in glycaemic control for all treatment groups was associated with a slight increase in minor hypoglycaemia (no significant difference between BIAsp 30 twice- or thrice-daily), no major hypoglycaemia was reported in any treatment group during the 16 weeks of the trial36.
These findings concurred with those from clinical trials, and showed that the use of BIAsp 30 treatment in clinical practice was both effective and safe in patients with type 2 diabetes mellitus who were considered to be poorly controlled on prior diabetes therapy45.
If the injection of BIAsp 30 is delayed 15 minutes after the start of a meal, the resulting AUCsg is similar to that of BHI 30 injected either immediately before or 15 minutes before a meal.47 BIAsp 30 therefore offers the patient a degree of flexibility in terms of injection timing, allowing individual adjustment for meal size and content without significantly affecting efficacy.

It can be started once daily in combination with oral antidiabetics and then can be intensified to twice and thrice daily dosing. Given the importance of post prandial glycemic control along with simplicity of dosing regimen, BIAsp 30 is an obvious choice for initiating insulin therapy and reducing the long term morbidity and mortality in patients with type 2 diabetes. 20-year follow-up in the Whitehall Study, the Paris Prospective Study, and the Helsinki Policemen Study.
Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57).
Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs.
The ADA says that preventing muscle loss by strength training is the key to an independent lifestyle as we age! Careful glucose monitoring and dose adjustments of insulin, including LEVEMIR, may be necessary in patients with renal dysfunction (see PRECAUTIONS, Renal Impairment).
At 16 weeks of treatment, the combined LEVEMIR-treated patients had similar HbA and fasting plasma glucose (FPG) reductions to NPH-treated patients (Table 1).
They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased urination, thirst and loss of appetite as well as acetone breath. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see PRECAUTIONS, Drug Interactions). In the early disease state, the first phase of the prandial insulin response is lost, resulting in hyperglycaemia. Thus, aggressive therapy is becoming the standard of care to prevent long-term complications of DM.
Premix insulin analogue preparations are composed of a single type of insulin that is modified to have dual-action PK profiles (a short-acting peak and a longer basal release) and are biphasic rather than truly premixed.
Thus, there is ample evidence which demands a better PPG control along with FPG, making premix insulin a desirable alternative regimen for targeted glycemic control.
This was then increased to thrice-daily (phase 3) after 32 weeks for patients that had not achieved this target. The finding of 41% patients achieving target HbA1c of < 7% with BIAsp 30 in Garber study35 has been corroborated by many other studies. Similarly Garber et al35 2006 found that inspite of increament in dasage from once to thrice daily, there were no major nocturnal hypoglycaemic events, and none of the patient withdrew from the study due to any hypoglycaemic event.
Being more physiological, it provides a significantly better postprandial blood glucose and HbA1c control compared with BHI 30, biphasic insulin lispro 25, NPH and insulin glargine.
Postprandial Blood Glucose Is a Stronger Predictor of Cardiovascular Events Than Fasting Blood Glucose in Type 2 Diabetes Mellitus, Particularly in Women: Lessons from the San Luigi Gonzaga Diabetes Study. LEVEMIR, after subcutaneous administration, has a terminal half-life of 5 to7 hours depending on dose.
Differences in timing of LEVEMIR administration (or flexible dosing) had no effect on HbA, FPG, body weight, or risk of having hypoglycemic episodes.
Untreated hyperglycemic events are potentially fatal.LEVEMIR is not intended for intravenous or intramuscular administration. Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patientsa€™ awareness of hypoglycemia.The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen or timing of dosing is changed.
However, considerable variability has been found in onset and duration of action, as well as peak insulin levels, with premixed human insulin.Therefore, premixed insulin analogues have been developed to more closely mimic physiological endogenous insulin secretion and meet the needs of patients. A compensatory mechanism may be initiated in the form of increased insulin production during the second stage of the prandial insulin response.
Premixed insulin is always an acceptable option as it provides both basal and prandial coverage in one injection.
The cumulative proportions of patients (per protocol population) that achieved HbA1c a‰¤6.5% was 24%, 66% and 77% for once-, twice- and thrice-daily BIAsp 30, respectively35. Overall glycemic control achieved with LEVEMIR was compared to that achieved with insulin glargine in a randomized, non-blinded, clinical study (Study B, n=320) in which patients with type 1 diabetes were treated for 26 weeks with either twice-daily (morning and bedtime) LEVEMIR or once-daily (bedtime) insulin glargine. The prolonged duration of activity of insulin detemir is dependent on injection into subcutaneous tissue.
After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.LEVEMIR can be administered once- or twice-daily. BIAsp 30 is a new premix analogue containing 30 % insulin aspart (rapid acting component) and 70% protaminated insulin aspart (intermediate acting component). These data show that the variable dosing regimen with BIAsp 30 enables patients to start and stay on premix analogue, allowing treatment intensity to keep pace with disease progression.
Insulins, including insulin detemir, exert their specific action through binding to insulin receptors.Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and fat and by inhibiting the output of glucose from the liver. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. As with other insulins, the requirements for LEVEMIR may need to be adjusted in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics).As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. The rat and rabbit embryofetal development studies that included concurrent human insulin control groups indicated that insulin detemir and human insulin had similar effects regarding embryotoxicity and teratogenicity.It is unknown whether LEVEMIR is excreted in significant amounts in human milk. It has been shown to have better post prandial and overall glycemic control than premix human insulin (BHI 30), lispro Mix 25 or neutral protamine Hagedorn (NPH) & insulin glargine in several randomised control trials. The inability of beta cells to maintain this over-production of insulin results in a reduced prandial insulin response and subsequent postprandial hyperglycaemia,3.4 a pre-diabetic state called impaired glucose tolerance (IGT). Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.Insulin detemir is a soluble, long-acting basal human insulin analog with a relatively flat action profile.
LEVEMIR-treated patients had a decrease in HbA similar to that of insulin glargine-treated patients.In a randomized, controlled clinical study (Study C, n=749), patients with type 1 diabetes were treated with once-daily (bedtime) LEVEMIR or NPH human insulin, both in combination with human soluble insulin before each meal for 6 months.
Absorption after intramuscular administration is both faster and more extensive than absorption after subcutaneous administration. Other injection site reactions with insulin therapy may include redness, pain, itching, hives, swelling, and inflammation. For this reason, caution should be exercised when LEVEMIR is administered to a nursing mother. The dosage of LEVEMIR should be individualized based on the physiciana€™s advice, in accordance with the needs of the patient.LEVEMIR should be administered by subcutaneous injection in the thigh, abdominal wall, or upper arm. Moreover, compared with BHI 30, the reduction in mean daily blood glucose with BIAsp 30 is achieved with fewer hypoglycaemic events. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Significant proportion of patients have achieved glycosylated hemoglobin target of <7%, even with once daily start in combinations with OADs.
Insulin detemir is distributed more slowly to peripheral target tissues since insulin detemir in the bloodstream is highly bound to albumin.Figure 1 shows glucose infusion rate results from a glucose clamp study in patients with type 1 diabetes. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.LEVEMIR should be inspected visually prior to administration and should only be used if the solution appears clear and colorless. Thus it has proved to be a better choice for insulin initiation in type 2 diabetic patients.
In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Also, therapy with BIAsp 30 can be intensified to twice and thrice daily in patients not achieving the targeted glycemic control. Its unique pharmacokinetic profile offers patients flexibility with regard to injection time, as efficacy is maintained even if injection is delayed 15 minutes after the start of a meal. Patients should be informed about potential risks and advantages of LEVEMIR therapy, including the possible side effects.
Patients should be offered continued education and advice on insulin therapies, injection technique, life-style management, regular glucose monitoring, periodic glycosylated hemoglobin testing, recognition and management of hypo- and hyperglycemia, adherence to meal planning, complications of insulin therapy, timing of dosage, instruction for use of injection devices and proper storage of insulin.
Patients should be informed that frequent, patient-performed blood glucose measurements are needed to achieve effective glycemic control to avoid both hyperglycemia and hypoglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, or skipped meals. Mixing LEVEMIR with insulin aspart, a rapid acting insulin analog, resulted in about 40% reduction in AUC() and C for insulin aspart compared to separate injections when the ratio of insulin aspart to LEVEMIR was less than 50%.

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Defronzo ra. pharmacologic therapy for type 2 diabetes mellitus


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