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Oral Semaglutide Seems Protected, Efficient in T2D Sufferers With Renal Impairment

Da Hee Han, PharmD August 20, 2018 The safety profile of oral semaglutide was similar to other GLP-1 based treatments Novo Nordisk announced new ...


August 20, 2018

The safety profile of oral semaglutide was similar to other GLP-1 based treatments

The safety profile of oral semaglutide was similar to other GLP-1 based treatments

Novo Nordisk announced new data from the Phase 3a PIONEER 5 trial which evaluated oral semaglutide in adult patients with type 2 diabetes and moderate renal impairment. 

PIONEER 5 (N=324) was a randomized, double-blind, placebo-controlled, parallel-group, 26-week trial that evaluated the safety and efficacy of oral semaglutide 14mg vs placebo in patients with type 2 diabetes and moderate renal impairment (eGFR 30 to 59mL/min/1.73m2) inadequately controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin. 

According to the primary statistical approach (treatment effect regardless of discontinuation of treatment or initiation of rescue medication), treatment with semaglutide was associated with statistically significantly greater reductions in HbA1c compared with placebo at week 26. In addition, patients treated with oral semaglutide achieved statistically significant and superior reductions in body weight vs placebo at week 26. 

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Using the secondary statistical approach (treatment effect while on treatment without use of rescue medication), results showed that semaglutide-treated patients had a statistically significantly greater HbA1c reduction vs placebo (1.1% vs 0.1%). Regarding body weight, there was a greater reduction with semaglutide vs placebo (3.7kg vs 1.1kg). Among patients who had baseline HbA1c of 8.0%, a greater proportion of semaglutide-treated patients achieved the American Diabetes Association (ADA) target of <7.0% at week 26 compared with those in the placebo arm (64% vs 21%). 

The safety profile of oral semaglutide was similar to other GLP-1 based treatments with mild to moderate nausea being the most common adverse event. 

“Renal impairment is a serious diabetes complication and people with this condition have limited oral anti-diabetic treatment options, and if approved oral semaglutide represents an efficacious new solution for these people,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. 

Semaglutide is currently available as a subcutaneous injection for the treatment of type 2 diabetes in adults.

For more information call or visit NovoNordisk.com.

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Human trial identifies frequent blood strain medicine as secure, efficient remedy for diabetes


Researchers on the College of Alabama at Birmingham Complete Diabetes Middle have found a secure and efficient novel remedy to cut back insulin necessities and hypoglycemic episodes in grownup topics with latest onset Sort 1 diabetes by selling the affected person’s personal beta cell operate and insulin manufacturing — the primary such discovery to focus on diabetes on this method.

The findings, revealed in the present day by Nature Medication, reveal that common oral administration of verapamil, a standard blood strain medicine first permitted for medical use in 1981, enabled sufferers to supply increased ranges of their very own insulin, limiting their want for insulin injections to stability out their blood sugar ranges.

The randomized, double-blind, placebo-controlled human trial recognized verapamil as a secure, efficient, and promising remedy — a groundbreaking discovering within the area of diabetes analysis.

“The info collected from our scientific trial offers us each indication to consider that people with Sort 1 diabetes have the promise of a remedy strategy that would scale back their exterior insulin necessities and enhance their blood sugar management and high quality of life, due to the results that verapamil has in selling the physique’s personal beta cell operate,” stated Anath Shalev, M.D., director of UAB’s Complete Diabetes Middle and principal investigator of the trial. “Whereas this analysis shouldn’t be an end-all remedy for Sort 1 diabetes, these findings are getting us nearer to disease-altering therapies that may allow people with Sort 1 diabetes to have extra management over their illness and keep a few of their physique’s personal insulin manufacturing.”

In 2014, Shalev’s UAB analysis lab found that verapamil utterly reversed Sort 1 diabetes in animal fashions and sought to check the results of the drug in human topics in a scientific trial, funded by a $ 2.1 million grant from the JDRF. Verapamil has been Meals and Drug Administration permitted and accessible for prescription for the remedy of hypertension for greater than three many years. Nonetheless, Shalev’s analysis marks the primary time that the drug has been examined for security and efficacy in treating Sort 1 diabetes.

Sort 1 diabetes happens as the results of one’s immune system attacking the beta cells within the pancreas that produce insulin to control and keep optimum blood sugar ranges. When beta cells are being destroyed, an individual’s capacity to supply insulin declines, inflicting blood sugar ranges to rise and making the individual an increasing number of depending on exterior insulin. The UAB scientific trial found that when a affected person takes verapamil, beta cell operate is preserved, enabling the physique to supply extra of its personal insulin. This lessened the scientific trial individuals’ reliance on exterior insulin, which all people with Sort 1 diabetes should have to successfully regulate their blood sugar ranges.

“At JDRF, we’re excited and inspired by the latest findings from the UAB Complete Diabetes Middle’s scientific trial. This information has the potential to alter how we take into consideration treating and in the end curing T1D,” explains Andrew Rakeman, Ph.D., assistant vp of analysis at JDRF. “We sit up for continued scientific research that can construct on and ensure these findings, increasing to further affected person populations and guiding how, when and in who verapamil may need probably the most impression in T1D.”

The verapamil scientific trial monitored 24 sufferers age 18 to 45, every over the course of 1 yr. Eleven sufferers acquired verapamil and 13 acquired placebo. All scientific trial individuals had been identified with Sort 1 diabetes inside three months of their begin within the trial and continued with their prescribed insulin pump remedy all through the length of the examine. Researchers monitored the placebo and verapamil teams’ whole every day dose of insulin, the quantity of insulin produced, the p.c change in insulin manufacturing, and their HbA1C ranges. As well as, the variety of hypoglycemic occasions that the sufferers skilled had been recorded, and the p.c of time every affected person registered in wholesome blood glucose ranges had been analyzed utilizing a steady glucose monitoring system.

“Though this can be a smaller pattern group, our trial outcomes give us promise that topics with Sort 1 diabetes have remedy choices and that we’re nearing a more practical solution to cope with this illness,” stated Fernando Ovalle, M.D., director of UAB’s Complete Diabetes Clinic and co-principal investigator of the examine. “Past verapamil permitting topics with Sort 1 diabetes the power to reside a life with much less exterior insulin dependence, these findings will impression the standard of life that they’ll have. Hopefully, by bettering total blood sugar management it’s going to additionally restrict their dangers for different comorbidities, together with coronary heart assault, blindness, kidney illness, and extra.”

Whereas this examine particularly addressed findings in grownup topics identified inside three months of the trial’s begin, Shalev notes that future long-term research are wanted to assist decide the impact of verapamil on each the pediatric Sort 1 diabetes inhabitants, and people with Sort 1 diabetes who’ve been residing with and/or identified with the illness longer than three months. Moreover, verapamil’s results on Sort 2 diabetes haven’t been examined or studied in potential managed trials; Shalev stated and future research that discover the potential for this routine to positively impression Sort 2 diabetes are due to this fact additionally wanted. Nonetheless, in mouse fashions of Sort 2 diabetes and in latest epidemiological research verapamil use has been related to decrease danger of growing Sort 2 diabetes and with higher blood sugar management.

“This trial’s outcomes affirm that we’re heading in the right direction and are getting into a brand new part of discovery because it pertains to this illness,” Shalev stated. “Diabetes impacts greater than 30 million folks in America alone, and hopefully our breakthrough will in the end result in approaches that may assist enhance the lives of all these affected by this illness.”



Protein inhibitor drug discovered to be secure and efficient in treating sufferers with acute myeloid leukemia


Ivosidenib, an experimental drug that inhibits a protein typically mutated in a number of cancers has been proven to be secure, leading to sturdy remissions, in a examine of acute myeloid leukemia (AML) with relapsed or refractory illness.

The multi-center Part I trial, led by researchers at The College of Texas MD Anderson Most cancers Middle, was designed to find out ivosidenib’s security and efficacy in therapy of sufferers with a type of AML wherein the enzyme isocitrate dehydrogenase 1 (IDH1) is mutated. IDH1 mutations happen in 6 to 10 p.c of AML sufferers. Findings are revealed immediately within the June 2 on-line concern of the New England Journal of Medication and introduced on the American Society of Medical Oncology Annual Assembly in Chicago.

This primary examine of ivosidenib in people, which enrolled sufferers between March 2014 and Might 2017, administered a each day dose of the focused IDH1 inhibitor to 258 sufferers.

“Ivosidenib, when administered orally as a single agent, was related to acceptable negative effects and induced sturdy and deep remissions,” stated Courtney DiNardo, M.D., assistant professor of Leukemia at MD Anderson. “Within the trial’s main evaluation cohort of 125 sufferers with IDH1-mutated relapsed or refractory AML handled on the really helpful 500 mg each day dose, ivosidenib led to an general response fee of 41.6 p.c and a whole remission fee of 21.6 p.c.”

The examine additionally reported that 30.four p.c of these 125 sufferers have been in full remission however with blood counts not totally restored. The general survival fee was 50.1 p.c at 18 months, as in comparison with historic general survival of lower than 5 months for sufferers with relapsed AML and two prior therapies.

“Amongst sufferers reaching full remission or full remission with partial hematologic restoration, 21 p.c had no residual detectable IDH1 mutations,” stated DiNardo. “Whereas the importance and prognostic impression of ongoing detection of IDH1 mutations stays unknown, additional analysis of adjustments in IDH1 mutations over time with ivosidenib remedy might be essential avenues of analysis.”



New outcomes reinforce COPAXONE 40 mg/mL as secure and efficient for RMS sufferers


Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) right now introduced as much as 7-year efficacy, security and tolerability outcomes from the Glatiramer Acetate Low-Frequency Administration (GALA) open-label extension examine of COPAXONE® (glatiramer acetate injection) 40 mg/mL administered subcutaneously three-times-a-week for the therapy of relapsing types of a number of sclerosis (RMS). The examine, together with the open-label section of the most important pivotal trial ever carried out for COPAXONE®, examined the long-term results as much as seven years of early begin (ES) and delayed begin (DS) therapy of COPAXONE® 40 mg/mL. Outcomes present that favorable annualized relapse and incapacity development charges are noticed in each sufferers persevering with COPAXONE® 40 mg/mL and sufferers switching from placebo to COPAXONE® 40 mg/mL. Moreover, no new or sudden opposed occasions emerged in sufferers receiving the therapy.

“The continued long-term efficacy, security and tolerability noticed within the GALA open-label extension examine is encouraging,” stated Daniel McBryan, M.D., Head of International Medical Affairs at Teva. “The outcomes reinforce COPAXONE 40 mg/mL as an efficient and secure therapy possibility for sufferers with RMS.”

Efficacy evaluation included publicity information from randomization till the final obtainable remark for each the ES and DS teams (median glatiramer acetate publicity of 5.5 and four.5 years, respectively). Annualized relapse fee for the whole long-term follow-up interval since randomization was Zero.26 for ES and Zero.31 for DS teams (P=.041), and roughly 50% of sufferers have been relapse-free in each teams. Time to first confirmed relapse was longer in ES vs DS sufferers (HR=Zero.815; 95% CI: Zero.693-Zero.959); P=Zero.0135). Time to 6-month confirmed incapacity development (CDP) and to EDSS four.Zero was comparable between ES and DS teams, and roughly 81% of sufferers in each teams have been free from 6-month CDP.

No new or sudden opposed occasions emerged in sufferers receiving COPAXONE 40 mg/mL for as much as 7 years. Opposed occasions have been usually delicate and in step with the well-established security profile of COPAXONE.

The poster, “Lengthy-term efficacy, security, and tolerability of three-times weekly dosing routine of glatiramer acetate in relapsing-remitting a number of sclerosis sufferers: As much as 7-year outcomes of the Glatiramer Acetate Low-Frequency Administration (GALA) open-label extension examine,” might be on show throughout Poster Session 6 on Friday, April 27 from 11:30 a.m. to five:30 p.m. PT.



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