Basal insulin therapy in type 2 diabetes quizlet,s view cover core prime,spelletjes 100 - Review


Strategies for insulin therapy in type 2 diabetes - medscape, Normalizing blood glucose and mimicking normal insulin secretion in patients with type 2 diabetes may prevent the onset and delay the progression of diabetic.
Early and aggressive initiation of insulin therapy for, Early and aggressive initiation of insulin therapy for type 2 diabetes: what is the evidence?. Insulin therapy in type 2 diabetes – nice cks, 2016-03-01 last revised in july 2016 back to top summary: insulin therapy in type 2 diabetes.
Outpatient insulin therapy in type 1 and type 2 diabetes, Review from jama — outpatient insulin therapy in type 1 and type 2 diabetes mellitus — scientific review — contextnewer insulin therapies, including the concept. New developments in insulin therapy for type 2 diabetes, Exogenous insulin is well established as the primary and lifesaving therapy for type 1 diabetes. Insulin degludec has been extensively studied in the BEGINA® programme in a range of patients with type 1 or type 2 diabetes. The BEGINA® programme investigated the efficacy and safety of insulin degludec in a range of patients with type 1 or type 2 diabetes. The demographic and baseline characteristics are usual for the type 1 diabetes and type 2 diabetes patients enrolled in these types of studies, and were similar across the treatment groups. All BEGINA® trials were randomised, controlled, open-label, treat-to-target, multicentre, involving more than 40 countries with few having an extension phase. HbA1c is the most widely accepted measure of overall, long-term glycaemic control and is predictive of diabetes complications.
Insulin degludec was used as basal-only + oral antidiabetic drugs (OADs) therapy in the five trials of BEGINA® programme and effectively improved long-term glycaemic control in insulin-naA?ve patients with type 2 diabetes (Figure 2). In BB T2 3582, the type 2 diabetes trial in which insulin degludec was used as part of a basal-bolus insulin regimen with insulin aspart, substantial improvements in HbA1c from baseline to the end of trial were observed (FigureA 3). Insulin degludec was compared with insulin glargine and insulin detemir (Trials BB T1 LONG 3583, FLEX T1 3770 and BBT1 3585) with mealtime insulin aspart as part of a basal-bolus regimen in type 1 diabetes. In all insulin degludec trials, FPG was measured at selected time points and at end of trial and analysed at a central laboratory. In all the basal-only type 2 diabetes trials, FPG decreased with both insulin degludec and comparator, and the observed mean FPG at end of trial was slightly lower with degludec than with comparator products. Insulin Degludec was associated with a consistently larger reduction in FPG than comparators in the five basal-only therapy type 2 diabetes trials, with a statistically significant difference in favour of insulin degludec in four of the five trials (Table 5). In patients with type 1 diabetes, FPG decreased substantially both with insulin degludec and insulin glargine in a basal-bolus regimen.
The lower laboratory-measured FPG observed with insulin degludec (TableA 5) was not counteracted by higher plasma glucose values at other times of the day relative to comparator insulin products since both groups had similar SMPG values at end of study for all nine time points measured (before and after meals, at bedtime, and during the night). 9-point SMPG profiles seemed similar for the two treatment groups at baseline and decreased in both groups by week 525 (FigureA 7). As shown in Table 7 (pooled insulin degludec type 2 diabetes trials), in the phase 3 trials, there was no consistent pattern in HbA1c reductions by age group, ethnicity, race, or baseline renal function for the degludec or comparator treatment groups.
The BEGINA? phase 3a studies assessed key efficacy end-points (HbA1c - primary end-point, FPG, SMPG) for insulin degludec across the spectrum of diabetes. There were three phase 3a non-inferiority trials in type 1 diabetes where insulin degludec was used in a basal-bolus regimen with insulin aspart at mealtimes.
There were six phase 3a trials in type 2 diabetes (five non-inferiority and one superiority trial).
In the superiority trial, insulin degludec lowered HbA1c significantly more than sitagliptin. The studies demonstrated that once daily dosing of insulin degludec administered in a fixed or flexible manner was non-inferior to insulin glargine administered with a fixed (inflexible) dosing schedule.
Administering insulin at fixed times may not be convenient for patients9 and may result in intentional omission.
In conclusion, insulin degludec appears to be non-inferior to existing basal insulins glargine and detemir in most clinical situations, whether used with oral antidiabetic agents or as a part of basal bolus therapy, in both type 1 and type 2 diabetes with lesser severe, nocturnal and overall hypoglycaemia. Findings also showed that while both lixisenatide and liraglutide lowered blood glucose (HbA1c) when added to optimally titrated insulin glargine, lixisenatide treatment resulted in fewer reports of gastrointestinal adverse events, a lower mean increase in heart rate and smaller increases from baseline to week 8 in pancreatic enzyme (amylase and lipase) levels.
These results were presented at the 74th Scientific Sessions of the American Diabetes Association, San Francisco, CA. In Europe, Lyxumia® (lixisenatide) is approved as a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus.
The Lyxumia pen is the winner of a number of innovative design awards, including the Good Design Award 2012 and the iF Product Design Award.
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs.


This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. BEGINA® is a phase 3a study programme which examined the efficacy and safety of insulin degludec once daily in three trials in type 1 diabetes and six trials in type 2 diabetes (Figure 1).1-8 It covered the spectrum of patients with diabetes who require insulin treatment (insulin-naive type 2 diabetes, insulin-treated type 2 and type 1 diabetes including basal-bolus therapy, basal plus oral therapy, and basal vs. In all insulin degludec phase 3 trials, the efficacy of once daily (OD) insulin degludec was established, as insulin degludec being non-inferior to comparators in reducing HbA1c (the measure of long-term glycaemic control) in all patient populations tested (insulin-naA?ve type 2 diabetes, insulin-treated type 2 and type 1 diabetes). The primary objective of the phase 3 trials was to confirm the efficacy of insulin degludec in terms of glycaemic control as assessed by the primary endpoint: change in HbA1c from baseline.
The primary endpoint (change in HbA1c from baseline to end of trial) was subject to a non-inferiority analysis in all trials except EARLY 3580 trial (superiority vs. The observed mean HbA1c at end of trial with insulin degludec dosed any time of day (free flexible) in EARLY 3580 trial4 was 7.2% and was comparable to the other trials in which insulin degludec was dosed at a fixed time. As shown in a representative plot of FPG over time from type 2 diabetes ONCE LONG 3579 trial 52 week (12 month), reductions in FPG were evident after 12 weeks of treatment and were maintained.
With degludec, the reduction in FPG was evident at the first post-baseline assessment (12 weeks), and the lower FPG was generally maintained until end of trial. Moreover, there was no consistent pattern in HbA1c reductions by other key demographic or disease characteristics such as sex, body mass index (BMI), or duration of diabetes for the Insulin degludec or comparator treatment groups. This includes insulin initiation in type 2 diabetes and its use with prandial insulin as part of basal bolus therapy in type 1 diabetes and type 2 diabetes. In all these trials, degludec was non-inferior to the comparators glargine and detemir with respect to change in HbA1c. One trial each used insulin degludec in a basala€“bolus regimen (with aspart) and a flexible regimen. The rationale for the comparison with sitagliptin was to investigate the efficacy and safety of adding insulin degludec instead of an additional OAD in patients inadequately controlled on 1a?’2 OADs. Flexible dosing is an attractive feature of this insulin that might improve adherence to therapy and conceivably improve outcomes. Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial.
Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: A 1-year, randomized, treat-to-target trial (BEGIN Once Long). Effect of ultra-long-acting insulin degludec versus sitagliptin addition in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Insulin degludec compared with insulin glargine in insulin-naA?ve patients with type 2 diabetes: a 26-week, randomized, controlled, Pan Asian, treat-to-target trial. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. Lowering of post-prandial glucose was measured as change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast, at week 8.
The most commonly reported adverse events in the study were symptomatic hypoglycemia and nausea. There was one case of severe symptomatic hypoglycemia in the lixisenatide arm and one case of mild asymptomatic confirmed pancreatitis in the liraglutide 1.8mg arm. Lyxumia is currently approved in over 40 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
Insulin degludec was non-inferior to insulin comparators as basal-only therapy and as part of a basal-bolus regimen (i.e.
The primary statistical analysis was an analysis of variance (ANOVA) method with treatment, anti-diabetic therapy at screening, sex and region as fixed factors and age and baseline HbA1c as covariates. HbA1c decreased primarily during the first twelve to sixteen weeks (Figure 2) when insulin dose usually goes titration.
Overall, good glycaemic control was achieved with insulin degludec in all five type 2 diabetes basal-only therapy trials, with end of trial HbA1c close to 7%. After 52 weeks, the mean observed HbA1c was close to 7.1% in both the treatment groups (Table 3).


Similar to the type 2 diabetes trials, the reduction in mean HbA1c was evident after the first 12 weeks of treatment, and the lower HbA1c level was maintained for at least 52 weeks based on the results from BB T1 LONG 3583 trial.
All trials were treat-to-target trials and used established basal insulins- glargine or detemir as comparators. Insulin degludec administered as part of a basala€“bolus regimen to patients with type 1 diabetes demonstrated a good safety and tolerability profile with a significantly lower FPG and nocturnal confirmed hypoglycaemia rate compared with insulin detemir. This allows patients who miss a dose, or for other reasons cannot inject their dose at the scheduled time, to administer degludec when this is discovered, without compromising on efficacy (glycaemic control). An easier dosing frequency (OD) and more flexible dosing translate into better adherence to therapy, which in turn would improve glycaemic control and decrease morbidity. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people with type 2 diabetes. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. The BEGINA® clinical trial programme included patients from North America, South America, Europe, Africa, and Asia.
With the exception of EARLY 3580 trial, all the trials were non-inferiority trials and efficacy was confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (ETD) (insulin degludec minus comparator) was below or equal to the non-inferiority limit of 0.4%. In these treat-to-target insulin degludec trials, non-inferiority of insulin degludec versus comparator with respect to change in HbA1c was confirmed, as the upper limit of the 95% CI for the ETD (Insulin degludec a?’ comparator) was well below the predefined non-inferiority limit of 0.4%.
Modest decreases were observed in HbA1c during the remaining part of the trials and improved glycaemic control was sustained up to 52 weeks of treatment.
Thus, the FPG reductions contributed to the improvements in long-term glycaemic control as measured by HbA1c. The estimated reduction in FPG was larger with insulin degludec than with glargine (TableA 6). Good glycaemic control was achieved with insulin degludec in all the trials, with end of trial HbA1c close to 7%. Lixisenatide is currently approved in Europe and an investigational drug in the United States, where it is not approved. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide. The trial populations were representative of the general diabetes population and the majority of exposed patients had type 2 diabetes, reflecting this populationa€™s large and growing size.
In the EARLY 3580 trial,4 which compared insulin degludec to sitagliptin, efficacy was confirmed if a statistically significant difference in change in HbA1c was observed (superiority).
In FLEX T1 3770 trial, 26 weeks of treatment with degludec (dosed in the evening) resulted in a larger reduction in estimated FPG compared with the insulin degludec flexible dosing arm which involved dosing at alternating narrow and wide dosing intervals (statistically significant). Insulin degludec was non-inferior to insulin glargine in all five trials, and lowered HbA1c regardless of patient status (insulin-naA?ve or insulin-experienced) and insulin regimen (basal-oral, basal-bolus, or flexible dosing).
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. In the insulin degludec phase 3 trials, consistently larger reductions in fasting plasma glucose (FPG) were also achieved with OD insulin degludec with a statistically significant difference in most of the trials. In three-arm trials (FLEX 3668 [type 2 diabetes] and FLEX T1 3770 [type 1 diabetes] trials),2,7 the primary analysis was insulin degludec flexible dosing vs. OD dosing is possible even in patients with high dose requirements (up to 160U), with a concentrated (U200) formulation of insulin degludec. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
The BEGINA® trials have all been conducted in a similar manner to allow for pre-planned meta-analyses.




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