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In many cases, OCI pursues cases involving Title 18 violations e. For more information on Basaglar KwikPen and insulin, go to www. FDA also was concerned that stevia might interfere with the absorption of carbohydrates and the conversion of food into energy within cells, as well as with effects on cardiovascular and renal systems. Two clinical trials with Basaglar were conducted: If you take the low carb diet for example, and use sweeteners, you will get a craving for sweet things much more often than usual, and we all know cravings are the curse of anyone watching their weight. The National Center for Complementary and Alternative Medicine also notes several other possible concerns:
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Try this Sweet Potato Gingerbread! Other natural sweetening options that are not artificial include pure stevia leaf, sugar alcohols such as xylitol or erythritol, raw agave nectar, pure raw honey although honey is not vegan , and pure, unrefined sugar cane. Real stevia leaf contains no calories and is made from pure stevia leaf native to South America; it is times sweeter than sugar.
However, stevia should only be purchased in a pure form without any chemicals or bleaching agents, so do your homework before buying one at the store. Major brands like Truvia are not real stevia, and are processed with a host of chemicals, fillers, and additives. Stevia can have a natural herbal flavor that some people find off-putting while other people enjoy it.
Sugar alcohols, such as xylitol and erythritol, are made by a fermentation process and are considered natural by FDA regulations. However, they can also lead to serious digestive upsets such as gas and bloat. Sugar alcohols are also often made from the fermentation of GMO corn, so purchase non-GMO verified brands if you decide to try them.
Still, raw blue agave has a pleasantly sweet flavor, and it is lower on the glycemic index than other natural sweeteners, making it a viable option for some individuals. Honey is technically a food designed for bees and not humans, and therefore is not considered vegan.
Still, some vegetarians and people eating plant-based diets choose to use honey. Learn why bees are important to our planet here! Unrefined cane sugar is made from freshly squeezed juice from real sugar cane and is marketed as organic cane sugar, evaporated cane juice, evaporated cane sugar, sucanat, turbinado, and demerara sugar on food labels. As you can see, all natural sugar alternatives have their own benefits and drawbacks; only you can decide which alternative is best for you!
We should all be eating more whole foods , such as fruits, vegetables, whole grains, beans, legumes, nuts, and seeds before we start relying on natural sweeteners for nutrition. Nourish yourself with a plant-based diet and then try a few of these natural sugar alternatives out to see how your body responds to them.
The app has more than 8, plant-based, allergy-friendly recipes, and subscribers gain access to ten new recipes per day. Lupus is a chronic, autoimmune disease that causes inflammation to the skin, joints, and vital organs because the immune system has gone awry. Everyone wishes to have a normal blood pressure reading as it is commonly known that high blood pressure can lead to hypertension and increase your risk for a cardiac event or stroke.
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Theobroma Theobroma cacao Theobroma grandiflorum Theobroma bicolor. Cocoa bean Cocoa butter Cocoa solids Chocolate liquor. Retrieved from " https: Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine has the following structural formula:. Basaglar is a clear, colorless, sterile aqueous solution of insulin glargine. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide.
Basaglar has a pH of approximately 4. The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. The pharmacodynamic profile for Basaglar was determined after subcutaneous administration of a single 0.
The median time to maximum effect of Basaglar measured by the peak rate of glucose infusion was approximately The pharmacodynamic profile of Basaglar following subcutaneous injection demonstrated sustained glucose lowering activity over 24 hours with no pronounced peak. A euglycemic clamp study in 20 patients with type 1 diabetes showed a similar pharmacodynamic profile with a sustained glucose lowering activity over 24 hours following a single 0.
After subcutaneous injection of 0. The time course of action of insulins, including insulin glargine, may vary between individuals and within the same individual. The pharmacokinetic profile for Basaglar was determined after subcutaneous administration of a single 0. The median time to maximum serum insulin concentration was 12 hours after injection. On average, serum insulin concentrations declined to baseline by approximately 24 hours. The in vitro activity of M1 and M2 were similar to that of insulin.
Age, Race, and Gender: Effect of age, race, and gender on the pharmacokinetics of Basaglar has not been evaluated. Effect of BMI on the pharmacokinetics of Basaglar has not been evaluated. In mice and rats, standard two-year carcinogenicity studies with another insulin glargine product were performed at doses up to 0. The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats statistically significant and male mice not statistically significant in acid vehicle containing groups.
These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown. Another insulin glargine product was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells Ames- and HGPRT-test and in tests for detection of chromosomal aberrations cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters.
In a combined fertility and prenatal and postnatal study of another insulin glargine product in male and female rats at subcutaneous doses up to 0. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
In general, the reduction in glycated hemoglobin HbA 1c with this other insulin glargine product was similar to that with NPH insulin. Randomized were adults with type 1 diabetes. Mean age was The mean BMI was approximately Observed HbA 1c data at 24 weeks were available from Regular human insulin was administered before each meal.
This other insulin glargine product was administered at bedtime. NPH insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily. In Study A, the average age was The mean duration of diabetes was In Study B, the average age was The majority of patients were Caucasian Insulin lispro was used before each meal. This other insulin glargine product was administered once daily at bedtime and NPH insulin was administered once or twice daily.
The average age was Type 1 Diabetes — Pediatric see Table 9. Patients were randomized to either this other insulin glargine product administered once daily at bedtime or NPH insulin administered once or twice daily. The mean duration of diabetes was 4. Similar effects on HbA 1c see Table 9 were observed in both treatment groups. A total of patients were randomized. Three patients randomized to Basaglar did not receive study drug and were not included in efficacy analysis.
The average age was approximately 59 years. This other insulin glargine product administered once daily at bedtime was as effective as NPH insulin administered once daily at bedtime in reducing HbA 1c and fasting glucose see Table The rate of hypoglycemia was similar in this other insulin glargine product and NPH insulin treated patients [see Adverse Reactions 6.
Regular human insulin was used before meals, as needed. This other insulin glargine product had similar effectiveness as either once- or twice daily NPH insulin in reducing HbA 1c and fasting glucose see Table 11 with a similar incidence of hypoglycemia [see Adverse Reactions 6. The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the ETDRS scale.
HbA 1c change from baseline was a secondary endpoint. Similar glycemic control in the 2 treatment groups was desired in order to not confound the interpretation of the retinal data. After this other insulin glargine product or NPH insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted or added.
This other insulin glargine product group had a smaller mean reduction from baseline in HbA 1c compared to the NPH insulin group, which may be explained by the lower daily basal insulin doses in this other insulin glargine product group see Table Both treatment groups had a similar incidence of reported symptomatic hypoglycemia.
Patients were also treated with insulin lispro at mealtime. This other insulin glargine product administered at different times of the day resulted in similar reductions in HbA 1c compared to that with bedtime administration see Table In these patients, data are available from 8-point home glucose monitoring.
The maximum mean blood glucose was observed just prior to injection of this other insulin glargine product regardless of time of administration. No patients in the other two arms discontinued for this reason. This other insulin glargine product given before breakfast was at least as effective in lowering HbA 1c as this other insulin glargine product given at bedtime or NPH insulin given at bedtime see Table Five-year Trial Evaluating the Progression of Retinopathy.
The numbers of retinal adverse events reported for this other insulin glargine product and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes. Mean baseline HbA 1c was 8. 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 progressions regardless of actual change in ETDRS score from baseline.
Retinopathy graders were blinded to treatment group assignment. The results for the primary endpoint are shown in Table 13 for both the per-protocol and Intent-to-Treat populations, and indicate similarity of this other insulin glargine product to NPH in the progression of diabetic retinopathy as assessed by this outcome.
The objective of the trial was to demonstrate that use of this other insulin glargine product could significantly lower the risk of major cardiovascular outcomes compared to standard care. 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.
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. Anthropometric and disease characteristics were balanced at baseline. The mean HbA 1c SD at baseline was 6. Vital status was available for The median duration of follow-up was 6. The mean HbA 1c SD at the end of the trial was 6.
The median dose of this other insulin glargine product at end of trial was 0. Eighty-one percent of patients randomized to this other insulin glargine product were using this other insulin glargine product at end of the study. The mean change in body weight from baseline to the last treatment visit was 2. Overall, the incidence of major adverse cardiovascular outcomes was similar between groups see Table All-cause mortality was also similar between groups.
Advise patients that they must never share a Basaglar KwikPen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions 5. Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions 5.
Inform patients to always check the insulin label before each injection [see Warnings and Precautions 5. Basaglar must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that Basaglar must NOT be diluted or mixed with any other insulin or solution [see Dosage and Administration 2.
Management of Hypoglycemia and Handling of Special Situations. Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia.
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, and skipped meals [see Warnings and Precautions 5.
Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy. This Patient Information has been approved by the U. Food and Drug Administration.
There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Do not share your Basaglar KwikPen with other people, even if the needle has been changed.
You may give other people a serious infection or get a serious infection from them. One pen contains multiple doses of medicine.
This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen. If you have any questions or problems with your Basaglar KwikPen, contact Lilly at LillyRx or call your healthcare provider for help. For more information on Basaglar KwikPen and insulin, go to www. Lantus , Toujeo SoloStar. By clicking Subscribe, I agree to the Drugs.
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