Delving into the Latest Updates on Insulin Degludec / Insulin Aspart with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

DegludecPlus, IDegAsp, Insulin aspart/insulin degludec

+ [15]

Target

INSR

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes MellitusDiabetes Mellitus, Type 1

Inactive Indication

Diabetes Mellitus, Insulin-Dependent, 2Diabetes Mellitus, Type 2

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/S

Inactive Organization

Novo Nordisk, Inc.

Drug Highest PhaseApproved

First Approval Date

JP (25 Dec 2012),

Diabetes Mellitus, Type 1

RegulationPriority Review (CN)

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Gene Sequence

Sequence Code 4857

The sequence is quoted from: *****

Sequence Code 31953

The sequence is quoted from: *****

Sequence Code 91440

The sequence is quoted from: *****

The purpose of this study is to collect information on how Ryzodeg® works in real-world patients.
Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment

Start Date18 Mar 2022

Sponsor / Collaborator

Novo Nordisk A/S

NCT04892069 / CompletedNot Applicable

A Retrospective, Single Centre, Non-interventional Study Investigating the Effect of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in Lebanon

The study is investigating Ryzodeg®,a medication prescribed to patients with type 2 diabetes mellitus.The study is being carried out to investigate the effect of Ryzodeg® on the change of glycated haemoglobin levels and other diabetes indicators. Participants participation will not affect their medical care. In this retrospective study, the study doctor will collect data from the participants patient files available at the study site. Participants will need to sign the informed consent form during a single visit. Participants files will be reviewed and data relevant to the study will be extracted, within 26 weeks before and after Ryzodeg® treatment initiation (total of 52 weeks). Chart review for all patients is expected to take approximately 12 weeks.

Start Date27 May 2021

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Insulin Degludec / Insulin Aspart

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100 Translational Medicine associated with Insulin Degludec / Insulin Aspart

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100 Patents (Medical) associated with Insulin Degludec / Insulin Aspart

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131

Literatures (Medical) associated with Insulin Degludec / Insulin Aspart

30 Sep 2024·Diabetes & metabolism journal

Efficacy and Safety of IDegAsp in a Real-World Korean Population with Type 2 Diabetes Mellitus

Article

Author: Jung, Sungeun ; Lee, Won-Young ; Kang, Shinae ; Jeong, Jin Sook ; Ahn, Yu-Bae ; Chun, Sung Wan ; Oh, Tae Keun ; Bae, Boram ; Dahaoui, Amine ; Jang, Hak Chul

Background: This study investigated the real-world efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in Korean adults with type 2 diabetes mellitus (T2DM), whose insulin treatment was switched to IDegAsp.Methods: This was a multicenter, retrospective, observational study comprising two 26-week treatment periods, before and after switching to IDegAsp, respectively. Korean adults with uncontrolled T2DM treated with basal or premix insulin (±oral antidiabetic drugs) were enrolled. The primary objective was to compare the degree of glycosylated hemoglobin (HbA1c) change in each 26-week observation period. The analyses included changes in HbA1c, fasting plasma glucose (FPG), body weight, proportion of participants achieving HbA1c <7.0%, hypoglycemic events, and total daily insulin dose (ClinicalTrials.gov, number NCT04656106).Results: In total, 196 adults (mean age, 65.95 years; mean T2DM duration, 18.99 years) were analyzed. The change in both HbA1c and FPG were significantly different between the pre-switching and the post-switching period (0.28% vs. –0.51%, <i>P<0.001; 5.21 mg/dL vs. –23.10 mg/dL, <i>P=0.005), respectively. After switching, the rate of achieving HbA1c <7.0% was significantly improved (5.10% at baseline vs. 11.22% with IDegAsp, <i>P=0.012). No significant differences (before vs. after switching) were observed in body weight change, and total daily insulin dose. The rates of overall and severe hypoglycemia were similar in the two periods.Conclusion: In real-world clinical practice in Korea, the change of insulin regimen to IDegAsp was associated with an improvement in glycemic control without increase of hypoglycemia, supporting the use of IDegAsp for patients with T2DM uncontrolled with basal or premix insulin.

01 Sep 2024·DIABETES OBESITY & METABOLISM

The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli‐D randomized controlled trial

Article

Author: SoliD trial investigators ; Souhami, Elisabeth ; Gu, Weijun ; Lauand, Felipe ; Liu, Ming ; Alvarez, Agustina ; Mu, Yiming ; Li, Yanbing ; Du, Qin ; Kuang, Hongyu ; Xu, Weiya ; Du, Jianling ; Zhang, Jiewen ; Chen, Li

Abstract:

Aim:

To compare the efficacy and safety of a fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin, insulin degludec plus insulin aspart (IDegAsp), in Chinese people with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drug(s) (OADs).

Methods:

In Soli‐D, a 24‐week, multicentre, open‐label, study, insulin‐naïve adults were randomized 1:1 to once‐daily injections of iGlarLixi (n = 291) or IDegAsp (n = 291), with continued metformin ± sodium‐glucose co‐transporter‐2 inhibitors. The primary endpoint was non‐inferiority in HbA1c change from baseline to week 24. Key secondary endpoints included superiority in HbA1c change and body weight (BW) change at week 24. Hypoglycaemia rates were also assessed.

Results:

At week 24, iGlarLixi showed non‐inferiority and superiority over IDegAsp in HbA1c reduction (least squares [LS] mean difference: −0.20 [95% confidence interval {CI}: –0.33, −0.07]; P < .001 for non‐inferiority; [97.5% CI: –0.35, −0.05]; P = .003 for superiority). iGlarLixi decreased BW and IDegAsp increased BW from baseline to week 24, with a statistically significant LS mean difference of −1.49 kg in favour of iGlarLixi (97.5% CI: –2.32, −0.66; P < .001). Event rates (per person‐year) for American Diabetes Association (ADA) Level 1, 2 or 3 hypoglycaemia were lower for iGlarLixi (1.90) versus IDegAsp (2.72) (relative risk: 0.71; 95% CI: 0.52, 0.98). No ADA Level 3 hypoglycaemia or unexpected safety findings were reported.

Conclusions:

In Chinese people with T2D suboptimally controlled with OADs, once‐daily iGlarLixi provided better glycaemic control with BW benefit and lower hypoglycaemia event rates versus IDegAsp.

01 Aug 2024·Internal medicine journal

Glycaemic outcomes in hospital with IDegAsp versus BIAsp30 premixed insulins

Article

Author: Varadarajan, Suresh ; Zhu, Jasmine ; Kyi, Mervyn ; Fourlanos, Spiros ; Walt, Joshua R ; Loughran, Julie ; Barmanray, Rahul D

Abstract:

Background and Aims:

IDegAsp (Ryzodeg 70/30), a unique premixed formulation of long‐acting insulin degludec and rapid‐acting insulin aspart, is increasing in use. Management of IDegAsp during hospitalisation is challenging because of degludec's ultra‐long duration of action. We investigated inpatient glycaemia in patients treated with IDegAsp compared to biphasic insulin aspart (BIAsp30; Novomix30).

Methods:

We performed a retrospective observational study at two hospitals assessing inpatients with type 2 diabetes treated with IDegAsp or BIAsp30 prior to and during hospital admission. Standard inpatient glycaemic outcomes were analysed based on capillary blood glucose (BG) measurements.

Results:

We assessed 88 individuals treated with IDegAsp and 88 HbA1c‐matched individuals treated with BIAsp30. Patient characteristics, including insulin dose at admission, were well matched, but the IDegAsp group had less frequent twice‐daily insulin dosing than the BIAsp30 group (49% vs 87%, P < 0.001). Patient‐days with BG <4 mmol/L were not different (10.6% vs 9.9%, P = 0.7); however, the IDegAsp group had a higher patient‐day mean BG (10.4 (SD 3.4) vs 10.0 (3.4) mmol/L, P < 0.001), and more patient‐days with mean BG >10 mmol/L (48% vs 38%, P < 0.001) compared to the BIAsp30 group. Glucose was higher in the IDegAsp group in the evening (4 PM to midnight) (11.6 (SD 4.0) vs 10.9 (4.6) mmol/L, P = 0.004), but not different at other times during the day.

Conclusions:

Inpatients treated with IDegAsp compared to BIAsp30 had similar hypoglycaemia incidence, but higher hyperglycaemia incidence, potentially related to less frequent twice‐daily dosing. With the increasing use of IDegAsp in the community, development of hospital management guidelines for this insulin formulation is needed.

5

News (Medical) associated with Insulin Degludec / Insulin Aspart

11 Sep 2024

·www.drugs.com

Weekly Insulin Injections As Effective for Diabetes as Daily Shots, Studies Show

WEDNESDAY, Sept. 11, 2024 -- Weekly insulin shots can help control both type 1 and type 2 diabetes as well as daily injections do, a pair of clinical trials have found. A new class of insulin called efsitora alfa has been designed to require injections only once a week, researchers said. Two phase 3 trials presented Tuesday at the European Association for the Study of Diabetes annual meeting in Madrid show that efsitora is as safe and effective as standard daily insulin shots: “A once-weekly insulin has the potential to simplify dose administration and diminish barriers to starting insulin therapy by means of a reduction in injection burden as compared with a once-daily insulin,” wrote the team behind the type 2 diabetes trial, which was led by Dr. Carol Wysham , an endocrinologist with the MultiCare Rockwood Center for Diabetes and Endocrinology in Spokane, Wash. "Traditionally, basal insulins are dosed once a day -- a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes," said Wysham said in a news release from drug maker Eli Lily. "Efsitora has the potential to address treatment burden and improve adherence -- all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins." In both clinical trials, which lasted 52 weeks, researchers randomly assigned participants to taking either efsitora or degludec insulin. The major difference in the results between the two trials involved hypoglycemic (low blood sugar) events. The type 2 diabetes trial found no statistically significant difference between efsitora and degludec when it came to hypoglycemia. But hypoglycemia occurred more often for type 1 diabetics taking efsitora (10%) compared with degludec (3%), results show. More work is needed to figure out the best dose “to maintain efficacy while mitigating the risk of hypoglycemia with weekly efsitora treatment in people with type 1 diabetes,” concluded the type 1 diabetes trial team led by Dr. Richard Bergenstal , executive director of the HealthPartners Institute's International Diabetes Center in Minneapolis. "People with type 1 diabetes need insulin every day. Currently, they can deliver the insulin using an automated insulin delivery system or by taking a daily basal insulin injection and multiple mealtime insulin injections each day," Bergenstal explained in an Eli Lilly news release . "This new data shows that with one dose a week of basal insulin, efsitora was able to achieve a similar A1C reduction as taking an injection of one of the most used background insulins every day. I look forward to further evaluation of these data, including ways to minimize hypoglycemia, so once-weekly insulin can be one option for personalizing the management of type 1 diabetes." The type 2 diabetes trial also found that efsitora worked well in diabetics even if they were taking a GLP-1 drug like Ozempic. “Given treatment guidelines and recommendations to incorporate GLP-1 receptor agonists earlier in treatment, along with their growing use worldwide, it is relevant to show that efsitora can be effectively and safely added to such therapy,” Wysham’s team concluded in a meeting news release. Type 1 diabetes is an inherited condition in which the immune system destroys or damages the body’s ability to make insulin. People with type 2 diabetes develop resistance to insulin, which also can destroy or damage the ability to make insulin. Results from the type 2 diabetes trial were published Sept. 10 in the New England Journal of Medicine , while results from the type 1 trial were published Sept. 10 in The Lancet . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 3Clinical ResultPhase 2

27 Jun 2024

·www.drugs.com

ADA: Inhaled Insulin Shows Promise for Adults With Type 1 Diabetes

THURSDAY, June 27, 2024 -- Inhaled insulin is associated with improved hemoglobin A1c (HbA1c) levels over 16 weeks among adults with type 1 diabetes when compared to usual care, according to a study presented at the annual meeting of the American Diabetes Association, held from June 21 to 24 in Orlando, Florida. Irl B. Hirsch, M.D., from the University of Washington in Seattle, and colleagues conducted a randomized trial that compared the efficacy of an inhaled insulin regimen (Afrezza) plus degludec insulin (Tresiba) to usual care for 17 weeks among adults with type 1 diabetes treated at 19 U.S. centers. The researchers found that more participants using the inhaled insulin regimen experienced significant improvements in HbA1c levels versus usual care, including 21 percent of those on inhaled insulin with HbA1c improvement >0.5 percent versus 5 percent for those receiving standard care. Among participants with HbA1c level ≥7 percent at baseline, 21 percent of those on inhaled insulin achieved the HbA1c goal of <7 percent, while no participants receiving standard care achieved the goal. Among participants who switched from using an automated insulin delivery system to using inhaled insulin plus degludec, 19 percent achieved an HbA1c improvement >0.5 percent. However, 26 percent of the patients in the inhaled insulin group had a worsening of HbA1c >0.5 percent versus 3 percent receiving standard care. "The INHALE-3 study’s findings will impact diabetes management by providing healthcare providers and patients with an alternative insulin delivery method," Hirsch said in a statement. "These results will assist in better informing clinical decisions and tailoring treatment plans to individual patient needs, potentially improving adherence, patient satisfaction, and overall outcomes." Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

24 Jun 2024

·www.drugs.com

Inhaled Insulin Could Help Folks With Type 1 Diabetes Avoid Needles

MONDAY, June 24, 2024 -- Inhaled insulin could be a better option than injections or pumps for some patients with type 1 diabetes , a new clinical trial shows. Patients using inhaled insulin ( Afrezza ) plus long-lasting insulin degludec injections had better control over their blood sugar than those assigned to receive usual care, researchers report. About 21% of those on inhaled insulin had a hemoglobin A1C improvement of greater than 0.5% during the study, compared with 5% of those on standard care, results show. The clinical trial’s results “will impact diabetes management by providing healthcare providers and patients with an alternative insulin delivery method,” said lead researcher Dr. Irl Hirsch , chair of diabetes treatment and teaching with the University of Washington in St. Louis. Inhaled insulin comes in powder form and is taken by mouth using a special inhaler, the National Institutes of Health (NIH) explained. It’s typically used at the beginning of each meal. For the study, 123 adults with type 1 diabetes were randomly assigned to take either inhaled insulin plus degludec insulin, or just stick with their usual multiple daily insulin injections or automated insulin pump. The trial lasted more than 16 weeks at 19 hospitals in the United States. People with diabetes have an A1C level of 6.5% or higher , according to the NIH. Among participants who had an A1C level of 7% or higher, about 21% of those on inhaled insulin dipped below 7% during the study. No participants receiving standard care achieved this goal. Further, 19% of participants who switched from using an automated delivery system to inhaled insulin had an A1C improvement greater than 0.5%, results show. It also proved a popular choice. More than half of study participants wanted to keep using inhaled insulin after the trial wrapped up, researchers said. However, inhaled insulin wasn’t for everyone. About 26% of patients in the inhaled insulin group had their A1C levels get worse, compared with 3% of those sticking to their standard care. The trial results were reported at the American Diabetes Association’s annual meeting in Orlando, Fla. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Insulin Degludec / Insulin Aspart

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AD06	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	IS	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	LI	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus	NO	Novo Nordisk A/S	21 Jan 2013
Diabetes Mellitus, Type 1	JP	Novo Nordisk A/S	25 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	AU	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	DK	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	FI	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	IN	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	MY	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	PL	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	SE	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TW	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TH	Novo Nordisk A/S	05 Nov 2009
Diabetes Mellitus, Type 2	Phase 3	TR	Novo Nordisk A/S	05 Nov 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2022	Not Applicable	-	535	IDegAsp	vaxovbhiyx(jehspsvfql) = coqscnvttl bbacywttqv (burfkhlmfd ) View more	-	01 Jun 2022
NCT01045447 \| NCT01814137 \| NCT01272193 \| NCT02906917 \| NCT01045707 \| NCT02762578 \| NCT01713530 \| NCT01365507 \| NCT01680341 \| NCT01513590 \| NCT01059812 \| NCT02648217 \| NCT01009580 (NN5401-3590, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	4,750	IDegAsp (Asian patients with T2D)	dhtmpxxqmq(lzqpiqrque) = xmwihmacrp llfrnrpinq (qsdpcmprtm, 18.35 - 38.99) View more	-	19 Jan 2022
NCT02821052 (Pubmed \| Adv Ther)	Not Applicable	Diabetes Mellitus	1,321	Insulin Degludec/Insulin Aspart	gdbeyqsykh(xduwzehusi) = lnqvbjwvpm wpioequqov (dzlwdgjxea, 3.4; 5.8) View more	-	20 Nov 2021
ADA2021	Not Applicable	Diabetes Mellitus, Type 2	324	Once-daily IDegAsp	tuhwemuoxg(jandufbcsz) = syfprgdrwr updzogucqj (jchimlmrgw ) View more	-	01 Jun 2021
				Basal insulin	tuhwemuoxg(jandufbcsz) = juyycgzwpc updzogucqj (jchimlmrgw ) View more
NCT02762578 (BOOST, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart	ppyghkkcni(wqlullebvl) = Non-inferiority for change from baseline to week 26 in HbA1c okcbnuetjx (zbwrttrvkk ) View more	Superior	01 Jul 2019
				biphasic insulin aspart 30
NCT01059812 \| NCT01009580 (BOOST INTENSIFY PREMIX I (NCT01009580) and BOOST INTENSIFY ALL (NCT01059812), Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp	ryptwlsyaz(ngbmxgenks) = similar for IDegAsp versus BIAsp 30 hobpicqtpa (ffyvjfrasn ) View more	-	01 Feb 2019
				BIAsp 30
NCT02762578 (BOOST, CTgov)	Phase 3	Diabetes Mellitus, Type 2	543	insulin degludec/insulin aspart (IDegAsp BID)	hjykodukkc(dlcownpwce) = efmhxaonms jyfqsktfvc (fxegljggfe, dxamcoicyt - egaqsfdhzj) View more	-	07 Dec 2018
				biphasic insulin aspart (BIAsp 30 BID)	hjykodukkc(dlcownpwce) = rukraildrn jyfqsktfvc (fxegljggfe, ngxqrmlhgb - rtagntnplf) View more
NCT01835431 (Pubmed \| Pediatr Diabetes) Manual	Phase 3	Diabetes Mellitus, Type 1	362	insulin degludec/insulin aspart	lyfogyfjxe(fuisimtpmh) = ebxqwchksv eafjdcfryw (udwgmpfsrq )	Non-inferior	01 Nov 2018
				Insulin detemir+insulin aspart	lyfogyfjxe(fuisimtpmh) = bzjsseutyw eafjdcfryw (udwgmpfsrq )
NCT02906917 (EASD2018)	Phase 3	Diabetes Mellitus, Type 2	-	IDegAsp QD	pcrqpbvpcn(prlywrpuxp) = xppgsxcjlr cuwllyvxbk (dkertijmfi ) View more	Positive	04 Oct 2018
				Glargine U100 QD + IAsp QD	pcrqpbvpcn(prlywrpuxp) = wqaqoookbo cuwllyvxbk (dkertijmfi ) View more
NCT02906917 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	532	Insulin Degludec+Insulin Aspart (Insulin Degludec/Insulin Aspart)	hmxagvqokz(fsahtybncw) = qqeppmdczd nfkofvrpze (vkxrripzls, kghltzvxye - jvcyhrlkwv) View more	-	28 Sep 2018
				Insulin Aspart+Insulin Glargine (Insulin Glargine + Insulin Aspart)	hmxagvqokz(fsahtybncw) = xbaepppepe nfkofvrpze (vkxrripzls, mdrmsweupa - xqfwhavtfp) View more