Efficacy of IDegLira Combined with Oral Antidiabetic Drugs vs CSII in Short-Term Intensive Intervention for Remission of Type 2 Diabetes : A Multicenter Non-Inferiority Randomized Controlled Clinical Study

Start Date01 Sep 2025

Sponsor / Collaborator

Nanfang Hospital

NCT07032688

/ RecruitingPhase 1

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes

The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.

Start Date11 Aug 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Insulin degludec

100 Translational Medicine associated with Insulin degludec

100 Patents (Medical) associated with Insulin degludec

928

Literatures (Medical) associated with Insulin degludec

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada

Article

Author: Mau, Godfrey ; Garcia, David A. ; Singh, Sumeet ; Spence, Michaela ; Goldenberg, Ronald ; Jensen, Morten Sall

AIM:

Patients with type 2 diabetes (T2D) with poor glycemic control despite use of non-insulin agents can experience delay in initiating insulin therapy and poor adherence to insulin therapy, predominantly due to the burden of multiple injections^1-3. This study aimed to determine the cost-effectiveness of insulin icodec, first once-weekly basal insulin, compared with long-acting basal insulins for improving glycemic control in adults with T2D in Canada.

MATERIALS AND METHODS:

The Swedish Institute of Health Economics T2D Cohort Model was used to analyse three T2D groups: insulin naïve (IN), basal insulin experienced (BIE), and basal-bolus insulin experienced (BBIE). Comparators included insulin glargine, insulin detemir, and insulin degludec. Comparative efficacy was informed by the phase 3 ONWARDS trials of insulin icodec and network meta-analyses (NMA). Time horizon was 40 years. Analyses considered disutilities resulting from vascular complications, age, gender, diabetes duration, hypoglycemia, and injection burden. A 1.5% annual discount rate was used for costs and effects. The average cost per unit for each treatment, accounting for the market share of available formats and biosimilars was calculated. Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).

RESULTS:

In all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.

LIMITATIONS:

Limitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.

CONCLUSIONS:

Insulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada.

01 Nov 2025·Diabetes Therapy

Efficacy and Safety of Once-Weekly Insulin Icodec in Indian Participants with Diabetes: Results from ONWARDS 1, 4, and 6 Studies

Article

Author: Mishra, Sunil ; Chandrappa, Manu ; Anil, Gayathri ; Murthy, L Sreenivasa ; Kar, Soumitra ; Mohan, Viswanathan ; Kesavadev, Jothydev

INTRODUCTION:

These analyses explored the efficacy and safety of once-weekly insulin icodec (icodec) in Indian participants with type 1 or type 2 diabetes (T1D/T2D) from the global ONWARDS 1, 4, and 6 studies.

METHODS:

This was a subgroup analysis of Indian participants enrolled in the multicentre, randomised, treat-to-target phase 3a studies: ONWARDS 1 (insulin-naïve T2D), ONWARDS 4 (basal-bolus treated T2D), and ONWARDS 6 (basal-bolus treated T1D). Participants were randomised 1:1 to receive once-weekly insulin icodec or once-daily comparator insulin (glargine U100 [ONWARDS 1 and 4] or degludec [ONWARDS 6]). The primary outcome was change in glycated haemoglobin (HbA_1c) from baseline to week 52 for ONWARDS 1, week 26 for ONWARDS 4 and 6.

RESULTS:

A total of 217 Indian participants were included. The estimated treatment differences (95% confidence interval, CI) in HbA_1c change for icodec versus once-daily comparator were 0.04% [- 0.46; 0.54], - 0.04% [- 0.41; 0.32], and 0.08% [- 0.67; 0.82] in ONWARDS 1, 4, and 6 studies, respectively. Time in range was similar between groups in the three studies. Icodec showed numerically lower rates of clinically significant hypoglycaemia compared to glargine U100 in ONWARDS 1 and 4, though a numerically higher rate of hypoglycaemic events was noted in ONWARDS 6 compared with degludec; results were consistent with global populations. Adverse event profiles were similar between groups, and no new safety findings were reported in the Indian subpopulation.

CONCLUSION:

Icodec demonstrated comparable efficacy and safety to once-daily basal insulins in Indian participants with T1D and T2D. These findings support icodec as a viable option for insulin initiation or intensification in Indian clinical practice.

TRIAL REGISTRATIONS:

ONWARDS 1: NCT04460885; ONWARDS 4: NCT04880850; ONWARDS 6: NCT04848480.

01 Oct 2025·JOURNAL OF DIABETES AND ITS COMPLICATIONS

Degludec insulin versus efsitora insulin in diabetes mellitus management: A systematic review and meta-analysis

Review

Author: Gallo Ruelas, Mariano ; Flávio-Reis, Victor Hugo Palhares ; Queiroz, Ivo ; Barbosa, Lucas Mendes ; de Oliveira, Helen Michaela ; Zamora, Fernanda Valeriano ; Cavalcante, Deivyd Vieira Silva

PURPOSE:

To compare the efficacy and safety of next-generation basal insulin efsitora versus insulin degludec in managing type 1 and type 2 diabetes.

METHODS:

We systematically searched PubMed, Embase, and CENTRAL databases until October 2024. This study followed PRISMA guidelines. Statistical analyses were performed using R version 4.4.1. The risk of bias was assessed using the RoB2 tool, and the quality of evidence was evaluated using the GRADE approach. This study was registered in PROSPERO under protocol CRD42024597806.

RESULTS:

Six randomized controlled trials involving 2590 patients were included in the analysis. Of these, 1376 (53.13 %) received efsitora insulin. No significant differences were observed between efsitora and degludec in glycemic efficacy outcomes, including HbA1c reduction, fasting blood glucose, weight change, and proportion of patients achieving HbA1c <7 %. Regarding safety outcomes, most endpoints, such as adverse events, injection site reactions, hypersensitivity, severe hypoglycemia, and mortality, were comparable between groups, with no significant subgroup effects. However, subgroup analysis revealed a lower incidence of nocturnal hypoglycemia with efsitora in patients with type 2 diabetes, and a higher rate of serious adverse events in patients with type 1 diabetes, suggesting potential population-specific differences in safety profiles.

CONCLUSION:

Efsitora and degludec insulins show similar overall efficacy and safety in the management of diabetes. However, subgroup analyses indicate that patient-specific factors, such as diabetes type, may influence the risk of certain adverse events. These findings support the importance of individualized insulin selection based on patient characteristics and risk profiles.

News (Medical) associated with Insulin degludec

30 Sep 2025

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April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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Drug ApprovalBiosimilar

29 Sep 2025

·www.prnewswire.com

Novo Nordisk resubmits Awiqli® to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes

Awiqli® (insulin icodec) injection, if approved, has the potential to be the first once-weekly basal insulin treatment available in the US for adult type 2 diabetes In adults with type 2 diabetes, the ONWARDS clinical trial program evaluated the change in A1C from baseline with Awiqli® compared to daily basal insulin1-5 Resubmission reflects Novo Nordisk's 100-year legacy of advancing diabetes care BAGSVÆRD, Denmark and PLAINSBORO, N.J., Sept. 29, 2025 /PRNewswire/ -- Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes. "With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk. "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that Awiqli® can help streamline the basal insulin injection regimen for people living with type 2 diabetes." The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 About Awiqli® In the US, Awiqli® is an investigational, novel once-weekly basal insulin analog designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. This resubmission is in response to the FDA's action letter received in Q3 2024. Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information References Rosenstock J, Bain C. S, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. The New England Journal of Medicine. 2023 10.1056/NEJMoa2303208 Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 (23)00093-1 Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes The ONWARDS 3 Randomized Clinical Trial. JAMA. 2023 Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 (23)00520-2 Bajaj H, Aberle J, Davies M, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naïve Type 2 Diabetes (ONWARDS 5). Annals of Internal Medicine. 2023 10.7326/M23-1288 Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25AWQ00001. September 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalPhase 2

29 Aug 2025

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Drug Approval

100 Deals associated with Insulin degludec

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KEGG	Wiki	ATC	Drug Bank
D09727	Insulin degludec	A10AE06	DB09564

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Novo Nordisk A/S	20 Sep 2017
Diabetes Mellitus	Japan	Novo Nordisk Pharma Ltd.	28 Sep 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 3	United States	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	France	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	Germany	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	Russia	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	South Africa	Novo Nordisk A/S	01 Sep 2009
Diabetes Mellitus, Type 1	Phase 3	United Kingdom	Novo Nordisk A/S	01 Sep 2009
Hypoglycemia	Phase 1	Germany	Novo Nordisk A/S	01 Aug 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec	pumpttdbja(xgeiqrmabt): P-Value = 0.0152	Positive	28 Feb 2025
				Once-Daily Insulin Degludec
NCT04795531 (ONWARDS 1-6 \| ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	mgnkotjpsj(odnrcgbedd) = fkarbffqrv fhmceegsmk (jizdsqovev, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	mgnkotjpsj(odnrcgbedd) = sbdeedhrvi fhmceegsmk (jizdsqovev, 0.05) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	cfuefjkozv(cdrroqcjql) = wujfctgxqc gbqinwjtsa (enjnqbcpis, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	cfuefjkozv(cdrroqcjql) = kcccsaauqy gbqinwjtsa (enjnqbcpis, 0.29) View more
NCT04538352 (TRANSITION-T2D, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Semaglutide+Insulin Degludec+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	vwflqjwlvh(zxetklbjcm) = wdqrjcsbtx knwipweyju (abeboctbkv, lwmwexkjxo - ykncaovhmi) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	vwflqjwlvh(zxetklbjcm) = wgcvcwoxro knwipweyju (abeboctbkv, mcvqbtbhgr - gtqsgkuxyq) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	jqwgewtuvu(vjinnitwta) = bvogrnfbnu ntlxhabjhp (bhywigrwgo, 0.4) View more	Positive	21 Jun 2024
				Standard care	jqwgewtuvu(vjinnitwta) = krpzxqkpxt ntlxhabjhp (bhywigrwgo, 0.6) View more
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	ffqjnischx(pdjhyulzdd) = rvtuyohdlr hqssanjwrx (wenxweomeb ) View more	Positive	21 Mar 2024
				Other long-acting insulins	ffqjnischx(pdjhyulzdd) = ksbflddris hqssanjwrx (wenxweomeb ) View more
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	Phase 2	-	912	Once-weekly insulin efsitora alfa	sujhfbisjb(ulqluewnmn) = jtuzsffzsn gusgnqttjw (pkmkuwrfwt ) View more	Positive	03 Oct 2023
				Once daily degludec	sujhfbisjb(ulqluewnmn) = rtflihiutt gusgnqttjw (pkmkuwrfwt ) View more
NCT04795531 (ONWARDS 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	588	Insulin icodec	ukwzprotnj(uvrgrccrug): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Insulin degludec
NCT04848480 (ONWARDS 6, EASD2023)	Phase 3	Diabetes Mellitus, Type 1	582	Insulin icodec	ktvviloubz(fydazucrok) = kovdxntmei tpyaccumno (jzuvxwzuke ) View more	Negative	03 Oct 2023
				Insulin degludec	ktvviloubz(fydazucrok) = quwnksyckx tpyaccumno (jzuvxwzuke ) View more
NCT03882970 (SURPASS-3 MRI, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 BMI \| fatty liver index \| triglycerides ... View more	-	Tirzepatide 5 mg	wokvusjvth(kszlbcvrju) = hikobomynq tvepsiklve (usgfeucths, 0.74)	Positive	03 Oct 2023
				Tirzepatide 10 mg	wokvusjvth(kszlbcvrju) = ezhpqvffsr tvepsiklve (usgfeucths, 0.74)

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