Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

Start Date15 Mar 2026

Sponsor / Collaborator

Sun Yat-Sen University

CTIS2025-521748-39-00

/ RecruitingPhase 4IIT

SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy

Start Date14 Nov 2025

Sponsor / Collaborator

Universita Cattolica Del Sacro Cuore

ChiCTR2500111276

/ Not yet recruitingPhase 4IIT

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

100 Clinical Results associated with Insulin degludec

100 Translational Medicine associated with Insulin degludec

100 Patents (Medical) associated with Insulin degludec

891

Literatures (Medical) associated with Insulin degludec

01 Feb 2026·AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY

Diabetes in pregnancy and major new advances in diabetes care using long-acting and ultralong-acting insulins

Review

Author: Seif, Karl E ; Higgs, Arielle J ; Reece, E Albert ; Drummond, Rosa F

Pregestational diabetes complicates 1% to 2% of all pregnancies. Achievement of euglycemia prevents adverse maternal, fetal, and neonatal outcomes. Insulin is the first line and the backbone of diabetes treatment in and out of pregnancy, but the delicate balance between stringent control and hypoglycemia, along with the complexity and interruption of multiple injections per day, continues to make glycemic control challenging. The ideal basal insulin has a flat pharmacodynamic profile with minimal variability and is relatively easy for patients and clinicians to use. Insulin analogs, such as insulins glargine and detemir, are the most common basal insulins used in pregnancy at this time, but insulin degludec, which has advantages like prolonged duration of action in the nonpregnant population, was recently shown to be equally as effective as detemir in pregnancy. The ease of a once-daily injection without an increased risk of hypoglycemia is attractive to patients and clinicians who wish to simplify insulin regimens. Furthermore, there are current clinical trials evaluating once-weekly basal insulin regimens in the general population. This would decrease basal injections from a minimum of 365 per year to 52 per year, potentially increasing adherence and improving glycemic control. This review will discuss the evidence for insulin degludec in pregnancy as well as discuss the potential benefits and drawbacks of once-weekly ultralong-acting basal insulins in pregnancy.

01 Jan 2026·DIABETES RESEARCH AND CLINICAL PRACTICE

A phase 1b, randomized, open-label study of once-weekly insulin GZR4 in patients with type 2 diabetes mellitus

Article

Author: Huang, Chenghu ; Wang, Xuhong ; Guo, Fengxue ; Hu, Ye ; Chen, Wei ; Tang, Chengyong

AIMS:

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of GZR4 in patients with type 2 diabetes mellitus (T2DM).

METHODS:

This randomized, active-controlled, phase 1b trial was conducted in adults with T2DM on stable daily basal insulin therapy. Eligible participants were randomized in 3:1 ratio within three cohorts to receive either a fixed once-weekly dose of GZR4 or once-daily insulin degludec (IDeg) subcutaneously for six weeks. Primary endpoints were incidence of adverse events (AEs), serious adverse events (SAEs), and hypoglycemia.

RESULTS:

The most commonly reported treatment-emergent AE across all treatment groups was hypoglycemia. No SAEs or severe hypoglycemia was observed. At steady state, the mean C_max of GZR4 was 289.0 ± 17.1 to 1,016.0 ± 262.4 ng/mL; mean AUC_{GZR4, 0-168h} ranged from 34,449.6 ± 2,055.7 to 137,064.2 ± 41,496.5 h.ng/mL. Mean change in FPG from baseline to week 6 was -1.77 ± 0.20 to -2.75 ± 0.71 mmol/L for GZR4 groups and -1.12 ± 0.36 mmol/L for IDeg group; corresponding change in HbA1c was -0.38 ± 0.64 % to -0.76 ± 0.14 % versus -0.13 ± 0.21 %.

CONCLUSIONS:

GZR4 was safe and well tolerated in patients with diabetes in present trial with pharmacokinetic and pharmacodynamic profiles enabling once-weekly dosing.

01 Jan 2026·Diabetology International

Insulin edema in slowly progressive type 1 diabetes: improvement following adjustment of insulin therapy

Article

Author: Yabe, Daisuke ; Okuno, Kana ; Harada, Norio ; Murakami, Takaaki ; Yamamoto, Kana ; Ueda, Yohei ; Okamura, Emi

Abstract:

Insulin edema is an uncommon complication that typically arises soon after initiating insulin therapy, most often in individuals with newly diagnosed diabetes or poorly controlled hyperglycemia. An old report from a single hospital in Africa showed an incidence of 3.5% among 491 insulin-treated individuals. Although the precise pathophysiology remains uncertain, proposed mechanisms include insulin-induced sodium retention, increased vascular permeability, and dysregulation of the renin–angiotensin–aldosterone system. Insulin edema has been described in both type 1 and type 2 diabetes; however, occurrence in slowly progressive type 1 diabetes mellitus (SPIDDM) is exceptionally rare. We report a woman with SPIDDM who developed bilateral lower-leg edema shortly after starting basal–bolus insulin therapy with insulin aspart and insulin degludec. She exhibited no signs of heart failure, liver disease, renal impairment, or allergic reaction to insulin. Cardiac function was normal on echocardiography, and B-type natriuretic peptide levels were within the reference range. She experienced marked edema and an approximately 7-kg weight gain after insulin initiation. Following modification of the insulin regimen and dietary sodium restriction (8 g/day of salt), the edema resolved rapidly within nine days without the use of diuretics. This case illustrates that insulin edema can occur even in individuals with SPIDDM. The observed improvement after insulin regimen adjustment likely reflects the combined influence of glycemic stabilization, fluid–electrolyte balance, and potential formulation-related factors, rather than a direct causal difference between insulin types. Clinicians should recognize this rare yet clinically important complication and adopt an individualized management approach that includes careful glycemic correction and, when appropriate, adjustment of the insulin regimen.

News (Medical) associated with Insulin degludec

30 Sep 2025

·www.einpresswire.com

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

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Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. 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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.

to view more data

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	brwapwskzi(nzrxxffvdy): P-Value = 0.0152	Positive	28 Feb 2025
				Once-Daily Insulin Degludec
NCT04795531 (ONWARDS 1-6 \| ONWARDS 1-5 \| ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	uqypuuapnv(lsglhqswhw) = jsjtxsyrxa tnfzqimfac (mywqmdlsfn, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	uqypuuapnv(lsglhqswhw) = rogsastrbx tnfzqimfac (mywqmdlsfn, 0.05) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	mbxxhkugtl(vcvxarzmvz) = akpmxccynf ysoeftodsn (uelegnxphq, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	mbxxhkugtl(vcvxarzmvz) = yovvvlucim ysoeftodsn (uelegnxphq, 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)	vlpvmkssgj(sacrwpfomq) = mpqisbzjic baakzsrplj (tiikbalzou, vuacjgcpsr - iyterqqtem) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	vlpvmkssgj(sacrwpfomq) = iaueewlwbb baakzsrplj (tiikbalzou, zhduihxnpf - mpudtomzne) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	nntcjfrdvl(cneefgfyqm) = vnkjtfzekz dcupkatwfr (rbxwekdtgk, 0.4) View more	Positive	21 Jun 2024
				Standard care	nntcjfrdvl(cneefgfyqm) = gkopfphwrw dcupkatwfr (rbxwekdtgk, 0.6) View more
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	bbohudwyxi(bcwkpogare) = hpxvgqweuh gzfxsabrqa (koxflcnhlf ) View more	Positive	21 Mar 2024
				Other long-acting insulins	bbohudwyxi(bcwkpogare) = gdazwfolwx gzfxsabrqa (koxflcnhlf ) View more
NCT04795531 (ONWARDS 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	588	Insulin icodec	rfbsqmdukw(szyhmfjqjk): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Insulin degludec
NCT03882970 (SURPASS-3 MRI, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 BMI \| fatty liver index \| triglycerides ... View more	-	Tirzepatide 5 mg	kmvdnfbept(htisjutuyn) = sbiqsrqjsv oorpxqcwxn (iwxiphuari, 0.74)	Positive	03 Oct 2023
				Tirzepatide 10 mg	kmvdnfbept(htisjutuyn) = wxhmbfpkpt oorpxqcwxn (iwxiphuari, 0.74)
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	Phase 2	-	912	Once-weekly insulin efsitora alfa	tmppywtkko(uufvmhkzqa) = ahzrbzmlax wugmfbajog (egawigipbg ) View more	Positive	03 Oct 2023
				Once daily degludec	tmppywtkko(uufvmhkzqa) = shmifihdhp wugmfbajog (egawigipbg ) View more
NCT04848480 (ONWARDS 6, EASD2023)	Phase 3	Diabetes Mellitus, Type 1	582	Insulin icodec	ttfxvoezjh(kbeqvsjuav) = xogsvdnaas ejfgsnxiqq (gsnnskwmhy ) View more	Negative	03 Oct 2023
				Insulin degludec	ttfxvoezjh(kbeqvsjuav) = zgketgafol ejfgsnxiqq (gsnnskwmhy ) View more

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