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FDA Advisory Panel votes 8-2 in favor of an insulin dosing label update for Dexcom's G5 CGM! Surprisingly, the research found that despite guidelines recommending metformin, only 58% of patients actually used metformin as their first diabetes medication.
Our mission is to help individuals better understand their diabetes and to make our readers happier & healthier. Our mission is to help individuals better understand their diabetes and to make our readers happier and healthier.
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Sometimes our quest for knowledge leads us to some interesting books, gadgets, and or a world of cool things.
Toujeo (insulin glargine [rDNA origin]) is an insulin injection approved for the treatment of type 1 and type 2 diabetes to improve glycaemic control in adult patients.
Toujeo's mechanism of actionToujeo contains an active ingredient called insulin glargine whose primary activity is to regulate glucose metabolism by controlling high blood sugar levels in patients with type 1 and type 2 diabetes.
Toujeo is a US FDA-approved insulin injection to improve glycaemic control in diabetes patients.
Toujeo was compared to once-daily Lantus, another insulin injection, in Phase III clinical trials. Sanofi also manufactures medical devices for diabetes including blood glucose monitoring systems. Constipation can also be a sign of inflammatory bowel disease, which comes in either of two forms: ulcerative colitis and Crohn's disease. To initially differentiate ulcerative colitis (UC) and Crohn's disease (CD), let us first describe them briefly. The treatment for both ulcerative colitis and Crohn's diseas are very extensive, and requires a great deal of money depending on its severity. The irritable bowel syndrome (IBS) is a very common condition but it is among the least understood.
Although constipation does not singly characterize the disease, it is part of its most common presenting pattern – constipation alternating with diarrhea. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Clipping is a handy way to collect and organize the most important slides from a presentation. LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. LANTUS is a recombinant human insulin analog for once daily subcutaneous administration with potency that is approximately the same as the potency of human insulin. In patients with type 1 diabetes, LANTUS must be used in regimens with short-acting insulin. The intended duration of activity of LANTUS is dependent on injection into subcutaneous tissue [see Clinical pharmacology (12.2)]. As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy [See Adverse Reactions (6.1)]. In clinical studies, there was no clinically relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. If changing from a treatment regimen with an intermediate-or long-acting insulin to a regimen with LANTUS, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted. If transferring patients from once-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is the same as the dose of NPH that is being discontinued. If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is 80% of the total NPH dose that is being discontinued. In patients with hypersensitivity to LANTUS or one of its excipients [See Warnings and Precautions (5.4)].
Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.
As with all insulin preparations, the time course of action for LANTUS may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the local blood supply, local temperature, and physical activity. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia [see Warnings and Precautions (5.3)]. Do not share disposable or reusable insulin devices or needles between patients, because doing so carries a risk for transmission of blood-borne pathogens. The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as beta-blockers, or intensified glycemic control. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including LANTUS. Due to its long duration of action, Lantus is not recommended during periods of rapidly declining renal function because of the risk for prolonged hypoglycemia. Due to its long duration of action, Lantus is not recommended during periods of rapidly declining hepatic function because of the risk for prolonged hypoglycemia.
Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia or hyperglycemia [See Drug Interactions (7)]. Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin.


Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The frequencies of treatment-emergent adverse events during LANTUS clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below. Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LANTUS [See Warnings and Precautions (5.3)].
Table 7 displays the proportion of patients experiencing severe symptomatic hypoglycemia in the Lantus and Standard Care groups in the ORIGIN Trial [see Adverse Reactions (cardiovascular safety)]. Retinopathy was evaluated in the LANTUS clinical studies by analysis of reported retinal adverse events and fundus photography.
LANTUS was compared to NPH insulin in a 5-year randomized clinical trial that evaluated the progression of retinopathy as assessed with fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Scale (ETDRS).
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Long-term use of insulin, including LANTUS, can cause lipodystrophy at the site of repeated insulin injections.
Weight gain can occur with insulin therapy, including LANTUS, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Insulin, including LANTUS, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. As with any insulin therapy, patients taking LANTUS may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. Rotation of the injection site within a given area from one injection to the next may help to reduce or prevent these reactions. Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LANTUS and may be life threatening.
The objective of the trial was to demonstrate that LANTUS use could significantly lower the risk of major cardiovascular outcomes compared to standard care. Overall, the incidence of major adverse cardiovascular outcomes was similar between groups (see Table 9). Cellulitis – Cellulitis caused by bacteria type into the skin usually by a cut, abrasions, or break in the skin.
The photos shown here of cellulitis cases are more severe than what may appear to be normal in the early stages.
This reddened skin or rash may signal a deeper infection, more serious than the inner layer of skin.
The study was a “retroactive cohort study,” meaning that it looked back at a group of patients and analyzed their health outcomes.
The study unfortunately did not include GLP-1 agonists – a common injectable drug class for treating type 2 diabetes that has been available since 2005. When you subscribe to Askipedia, you will get the latest entertaining posts delivered directly to your inbox for free! The constipation that is present in these cases is due to bowel obstruction and slowed transit.
Our body has a remarkable trait of being tolerant towards the normal bacteria residing in the digestive tract, but in the presence of other ingested pathogens, the body immediately mounts up immune defenses to eliminate the invaders swiftly. Ulcerative colitis is a chronic disease which is due to inflammation limited to the colon and the rectum, while Crohn's disease is an autoimmune condition affecting any portion of the gastrointestinal tract, but most often affecting the distal part of the small intestine as well as the colon.
One cannot even assess accurately his or her risk for colon cancer once these have started, since its being chronic in origin poses more threats – and more possibilities - for complications.
Patients with the irritable bowel syndrome typically feel very uncomfortable especially when symptoms include dyspepsia, vomiting, heartburn and nausea.
Constipation can be merely a break in the balance of foods which can cause it, and foods that can prevent it. LANTUS exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.
As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered drugs or meal patterns. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements. The dosage of LANTUS should be individualized under the supervision of a healthcare provider in accordance with the needs of the patient. This dose reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].
Changes to an insulin regimen should be made cautiously and only under medical supervision.
Patients being switched from twice daily NPH insulin to once-daily LANTUS should have their initial LANTUS dose reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycemia [see Dosage and Administration (2.3)]. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia. Tables 5, and 6 and 7 summarize the incidence of severe hypoglycemia in the LANTUS individual clinical trials. In the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type 1 diabetes.
The numbers of retinal adverse events reported for LANTUS and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes.
Patients had type 2 diabetes (mean age 55 yrs) with no (86%) or mild (14%) retinopathy at baseline. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.


Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. The doctor may also suggest blood tests, a wound culture or other tests to help rule out blood clots in the leg veins. Once under the skin, the bacteria can spread rapidly, entering the lymph nodes and the bloodstream and spread throughout the body.
However, in this idiopathic inflammatory bowel disease, this tolerance towards the normal intestinal microflora becomes disrupted, resulting to defects in the mucosa. Genetics also play a role in the presence of these diseases, since there are reports that it runs in families, and it has associations with some genetic syndromes.
The typical diet nowadays can highly induce constipation, and fatty food is one of the major culprits.
When LANTUS and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and a delayed time to maximum effect for regular human insulin was observed. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Patients treated with insulin, including LANTUS, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. In phase 3 clinical trials of LANTUS, increases in titers of antibodies to insulin were observed in NPH insulin and insulin glargine treatment groups with similar incidences. The first co-primary endpoint was the time to first occurrence of a major adverse cardiovascular event defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke. Cellulitis in the lower leg is characterized by signs and symptoms that may be similar to clot occurring deep in the veins, such as warmth, pain and swelling (inflammation). In the future, we look forward to the results of the GRADE study, which aims to conclude which second-line drug for type 2 diabetes is most effective; unfortunately, however, this study will not include SGLT-2 inhibitors or any fixed dose combination drugs, which we believe will be a very limiting factor from understanding real life outcomes. Good glycaemic control is an important part of diabetes care as both hyperglycaemia (elevated blood sugar levels) and hypoglycaemia (low blood sugar) may lead to chronic complications of diabetes.
Thus, the pathogenesis of both conditions is both an interaction of both external (otherwise called exogenous, such as luminal flora) and host factors. But then, regardless of these genetic tendencies, the quality of life is very useful in the evaluation of patients with inflammatory bowel disease. Contrary to popular belief, laxatives should be used only when someone fails to respond to the natural ways used to treat constipation. The total bioavailability of the mixture was also slightly decreased compared to separate injections of LANTUS and regular human insulin. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered. The primary outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. The second co-primary endpoint was the time to the first occurrence of CV death or nonfatal myocardial infarction or nonfatal stroke or revascularization procedure or hospitalization for heart failure.
While we understand that few risks are attractive for those designing the studies, we believe SGLT-2 research could have been included as a useful arm. It takes a unique approach of engaging with people suffering with diabetes, derives insights from it and forms a partnership to offer diagnostics, therapies, services and devices.
Although these diseases share the same mechanism of pathogenesis, they have very different clinical manifestations.
Preventive measures are still particularly important in order to avoid these alarming diseases, all of which merit special medical attention. Severe hypoglycemia requiring the assistance of another person or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with LANTUS. Patients with pre-specified post-baseline eye procedures (pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic retinopathy) were also considered as 3-step progressors regardless of actual change in ETDRS score from baseline. The company markets injectable, inhaled and oral medications for type 1 or type 2 diabetes. Its incidence varies among different locations, but it is more common in developed countries. The mean change in body weight from baseline to the last treatment visit was 2.2 kg greater in the LANTUS group than in the standard care group. The peak age for their onset is between the ages of 15 and 30 years old, with a second peak age reported to be between 60 and 80 years old. In conjunction with intake of the right amounts of fluid and fibers, inflammatory bowel diseases become relatively out of reach.
The results for the primary endpoint are shown in Table 8 for both the per-protocol and Intent-to-Treat populations, and indicate similarity of Lantus to NPH in the progression of diabetic retinopathy as assessed by this outcome. For patients with type 2 diabetes, 59% were treated with a single oral antidiabetic drug, 23% had known diabetes but were on no antidiabetic drug and 6% were newly diagnosed during the screening procedure. Fifty nine percent of participants had had a prior cardiovascular event and 39% had documented coronary artery disease or other cardiovascular risk factors.



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