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

CTRI/2026/01/100469

/ Not yet recruitingNot Applicable

An open label, balanced, randomized, two-treatment, twosequence,two-period, single-dose, crossover pharmacokinetic andpharmacodynamic bioequivalence study of Insulin DegludecInjection 100 Units/mL Manufactured by Jilin HuishengBiopharmaceutical Co., Ltd. for Lupin Ltd, India comparing withInsulin Degludec Injection (TRESIBA ) of Novo Nordisk inhealthy, adult, human participants using Euglycaemic clamptechnique under fasting conditions. - NIL

Start Date22 Jan 2026

Sponsor / Collaborator

Lupin Ltd

CTIS2025-521748-39-00

/ Not yet recruitingPhase 4IIT

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

Start Date14 Nov 2025

Sponsor / Collaborator

Universita Cattolica Del Sacro Cuore

100 Clinical Results associated with Insulin degludec

100 Translational Medicine associated with Insulin degludec

100 Patents (Medical) associated with Insulin degludec

929

Literatures (Medical) associated with Insulin degludec

01 Sep 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Pharmacokinetics and pharmacodynamics studies of different types of insulin with the canine euglycemic clamp

Article

Author: Chen, Chao ; Yuan, Chenxing ; Zhu, Difeng

Diabetes mellitus is a globally prevalent metabolic disorder with insulin therapy as its core intervention. Premixed insulins provide combined basal and prandial glucose control but lack systematic nonclinical validation of component interactions and species translation rules. This study evaluated the pharmacokinetic and pharmacodynamic profiles of insulin degludec (IDeg), insulin aspart (IAsp) and their 70/30 premixed formulation using a Beagle dog euglycemic clamp model. Twelve dogs received 0.75 IU/kg subcutaneous doses of each formulation in a randomized single-dose three-period crossover design with 7-day washouts. Blood glucose was clamped at 5.0 mmol/L for 24 hours while monitoring glucose infusion rate, plasma insulin and serum C-peptide. Drug concentrations were quantified by LC-MS/MS, and component interactions were assessed using Sigmoid-Emax and Loewe models. The clamp maintained stable blood glucose across all groups with no clinical hypoglycemia. Co-formulation induced modest shifts in time to maximum plasma concentration. Dose-normalized exposures were comparable between single and combined formulations with relative bioavailability below 110%. Elimination parameters remained unchanged supporting independent clearance pathways. IDeg exerted long-acting glucose-lowering effects while IAsp had rapid onset and short duration. IDegAsp integrated both dual characteristics. The C-peptide curve of IDeg closely resembled that of IDegAsp. Glucose infusion rate profiles of IAsp and IDegAsp were similar despite morphological differences. Both models confirmed additive rather than synergistic interactions. Marked interspecies differences necessitated component-specific bidirectional correction for clinical dose extrapolation. This study confirms IDegAsp achieves complementary glycemic control via independently acting components without significant interference, providing robust nonclinical support and a reference framework for premixed insulin development.

01 Aug 2026·DIABETES OBESITY & METABOLISM

Impact of Time of Injection on the Efficacy and Safety of iGlarLixi Versus IDegAsp in Chinese People With Type 2 Diabetes: Exploratory Analysis of the Soli‐D Study

Article

Author: Du, Qin ; Alvarez, Agustina ; Lauand, Felipe ; Wang, Juan ; Liu, Tong ; Kang, Lei ; Liu, Ming ; Li, Xin ; Melas‐Melt, Lydie

ABSTRACT:

Aims:

To compare the efficacy and safety of the fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin degludec plus insulin aspart (IDegAsp) according to the injection time of IDegAsp.

Materials and Methods:

The 24‐week, multicentre, randomised, open‐label Soli‐D study enrolled Chinese adults with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drugs (OADs). This exploratory analysis evaluated glycaemic efficacy, body weight, basal insulin daily dose and hypoglycaemia outcomes with once‐daily iGlarLixi (injected before breakfast) versus IDegAsp (injected before breakfast, lunch or dinner).

Results:

Of 582 participants, 291 received iGlarLixi, with injections self‐administered before breakfast, and 291 received IDegAsp, with injections self‐administered before breakfast ( n = 139), lunch ( n = 54) or dinner ( n = 98). Glycated haemoglobin (HbA1c) reductions from baseline to Week 24 were greater with iGlarLixi than IDegAsp injected before lunch (least squares mean difference −0.24% [−2.3 mmol/mol]) or dinner (−0.29% [−3.2 mmol/mol]), and slightly greater than IDegAsp injected before breakfast (−0.12% [−1.3 mmol/mol]). Average 2‐h postprandial glucose (2‐h PPG) reductions were also greater with iGlarLixi than IDegAsp, regardless of injection time. iGlarLixi provided additional benefits, including reduced body weight, lower total insulin doses and less hypoglycaemia risk compared with IDegAsp in all injection‐time subgroups.

Conclusions:

Once‐daily iGlarLixi, injected before breakfast, was associated with improved HbA1c control and greater average 2‐h PPG reductions compared with IDegAsp, regardless of injection time, in Chinese adults with T2D suboptimally controlled with OADs.

01 Aug 2026·DIABETES OBESITY & METABOLISM

Efficacy and Safety of Once‐Weekly and Once‐Daily Basal Insulins in Type 1 Diabetes Mellitus: A Systematic Review and Network Meta‐Analysis of Clinical Trials

Review

Author: Costa, Beatriz ; Alves, Carlos ; Mendes, Diogo ; Penedones, Ana ; Amaral, Ricardo

ABSTRACT:

Aims:

Once‐weekly basal insulins, icodec and efsitora alfa, were developed to improve treatment adherence and glycemic control and appear to be as effective as once‐daily degludec in reducing HbA1c in type 1 diabetes (T1DM). However, higher rates of clinically significant hypoglycemias were associated with both once‐weekly insulins. This network meta‐analysis compares the efficacy and safety of once‐weekly and once‐daily basal insulins in T1DM.

Methods:

PubMed and Embase were searched (up to April, 2025) to identify phase 3 clinical trials evaluating basal insulins in T1DM (icodec, efsitora alfa, degludec 100, glargine [100 and 300], detemir, and NPH). Change in HbA1c and weight, risk of hypoglycemias (overall and severe), and serious adverse events (AEs) were assessed at week 26 and 52.

Results:

Nineteen studies were included. At week 52, icodec reduced HbA1c more than degludec 100 (−0.17% [95% CrI: −0.28; −0.06]), glargine 100 (−0.17% [95% CrI: −0.32; −0.02]), detemir (−0.17% [95% CrI: −0.32; −0.02]), and NPH (−0.59% [95% CrI: −0.85; −0.34]), while efsitora alfa reduced HbA1c more than NPH (−0.45% [95% CrI: −0.70; −0.19]). Icodec showed a higher overall hypoglycemia risk at week 52 compared with degludec 100 (OR 1.64; 95% CrI 1.07–2.54) and detemir (OR 2.08; 95% CrI 1.01–4.39), but no increased risk of severe hypoglycemias or serious AEs.

Conclusions:

In T1DM, once‐weekly basal insulins appear broadly comparable in reducing HbA1c at week 52. Although icodec showed a higher overall hypoglycemia risk, evidence suggests a comparable risk of severe hypoglycemias between treatments.

101

News (Medical) associated with Insulin degludec

21 Aug 2026

·www.pharmaceutical-technology.com

Eli Lilly’s weekly insulin jab Onswik set for NHS use if approved

The jab’s availability will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. Credit: Halfpoint/Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national coverage, subject to marketing authorisation. Lilly’s Onswik is a pre-filled injection pen containing insulin that only needs administering once a week. Its availability marks a big advancement for type 2 diabetic patients who rely on daily insulin injections, with initial forecasts that a switch to Lilly’s product could cut the number of injections each patient needs by 85%. It will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. While the recommendation means Onswik will be covered on England’s National Health Service (NHS), an approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) still needs to arrive first for the product to be available. A UK marketing authorisation is largely expected given the pre-emptive NICE recommendation. Onswik already secured a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2026, signifying a welcome sentiment with regulators so far. NICE based its decision on data from Lilly’s Phase III QWINT programme. Results demonstrated that Onswik controls blood glucose levels as well as two widely used long-acting insulins, insulin degludec and insulin glargine, which are taken to keep blood sugar steady throughout the day. It means people switching to the weekly injection can expect similar blood glucose control to their current treatment, NICE said. Type 2 diabetes is a common condition where the body cannot make enough of a hormone called insulin, or the insulin it makes does not work properly. Administering insulin helps the body better regulate glycaemic levels. Helen Knight, director of medicines evaluation at NICE, said: “Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject. This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding.” The relatively straightforward decision for Onswik contrasts a rockier UK reimbursement journey for Lilly’s Alzheimer’s therapy Kisunla (donanemab). In June 2025, NICE rejected NHS use of the drug based on the narrow window of clinical benefits. Lilly appealed the decision, with NICE referring the review back to its appraisal committee in March 2026. The UK’s reimbursement landscape has caused friction with other drugmakers recently. Bristol Myers Squibb (BMS) aligned UK and US prices for schizophrenia treatment Cobenfy, even threatening to walk away from the UK market if NICE did not recognise the drug’s clinical value. Separately, AstraZeneca and MSD have previously halted investment for UK expansion plans in the past year, criticising an unwelcoming and uncompetitive pharmaceutical environment. Given the size of the patient population for insulin products, NICE’s nod for Onswik will be a welcome one for drugmakers. Regardless, insulin represents a product that is far more accessible in the UK than the US. According to research , US prices for insulin products were nearly ten times as high as prices in 33 OECD comparison countries in 2022. The history of insulin coverage in the US has been dominated by complex rebate systems and a prevalence of pharmacy benefit managers.

Phase 3Drug Approval

20 Aug 2026

·firstwordpharma.com

UK cost-effectiveness body backs Lilly's once-weekly insulin ahead of approval

Despite still being under review by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), the country's cost-effectiveness body said Thursday that Eli Lilly's Onswik (insulin efsitora alfa) can be used on the NHS as an option to treat type 2 diabetes in adults. The once-weekly basal insulin is also under regulatory review in the US, while approval in the EU is expected shortly following a recent positive recommendation. "Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject," said Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence (NICE).NICE said that its draft recommendation — which will only be finalised once Onswik is approved by the MHRA — is based on studies showing that the once-weekly basal insulin controls blood glucose levels as well as two widely used long-acting insulins, namely Novo Nordisk's Tresiba (insulin degludec) and Sanofi's Lantus (insulin glargine). The cost-effectiveness body noted that switching to Onswik could cut the number of injections each patient needs by 85%, offering particular benefit to some frailer people, and those with sight loss, limited hand movement, learning disabilities or difficulty following the steps involved. NICE indicated that Onswik can be used alone or alongside other treatments for type 2 diabetes, adding that healthcare professionals and patients should discuss the benefits and disadvantages of available options together. The agency directed them to then "choose the least expensive treatment that meets the person’s needs, taking account of dosage, administration costs and price."While NICE said the list price of Onswik is currently confidential, a cost comparison suggests that overall costs "are similar to or lower than" overall costs for basal insulin intended for administration once or twice a day.Earlier this year, Novo gained FDA approval for its once-weekly, long-acting basal insulin, dubbed Awiqli (insulin icodec-abae), for use in adults with type 2 diabetes as an adjunct to diet and exercise. The product is also authorised in a number of other markets, including the EU, Canada, Australia, Japan, Switzerland and China.

Drug Approval

19 Aug 2026

·www.fiercepharma.com

Lilly’s long-acting insulin wins NICE blessing ahead of potential UK approval

For patients living with Type 2 diabetes in the United Kingdom, a more convenient treatment option may be on the horizon after the country's drug price watchdog recommended Eli Lilly’s once-weekly insulin injectable, Onswik, for coverage on the National Health Service. The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s drug cost assessor, determining whether a new drug’s price-to-benefit ratio merits coverage via the publicly funded NHS. The agency's seal of approval for Onswik means hundreds of thousands of patients with type 2 diabetes could eventually switch to a weekly injection and reduce their annual injections by 85%, should Lilly's long-acting option score approval in the country. The Onswik option could be particularly valuable to patients who need assistance with their insulin injection because of factors like sight loss, frailty, limited hand movement or difficulty following the necessary steps, according to final draft guidance from NICE issued early Thursday U.K. time. Switching to weekly injections also could reduce those patients' dependence on caregivers and healthcare workers and offer more flexibility in their day-to-day lives, the drug value appraiser added. A Lilly spokesperson told Fierce that the pharma is now "awaiting a decision from the MHRA on marketing authorization." “This recommendation is an important step towards giving people with type 2 diabetes greater flexibility in how their condition is managed,” Douglas Twenefour, head of clinical at Diabetes UK, said in a press release. Younger patients with type 2 diabetes may also benefit from Onswik if the weekly schedule helps them balance treatment with their working life. NICE based its recommendation on data from Lilly’s late-stage QWINT-1, QWINT-3, and QWINT-4 clinical trials. The results showed non-inferior A1C reduction with Onswik compared to daily insulin in patients taking insulin for the first time, patients who previously took daily insulin and patients who previously used daily insulin and mealtime insulin. Overall, Onswik controlled blood glucose as well as two commonly used daily insulins, insulin degludec and insulin glargine, and maintained a similar safety profile. “This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding,” Helen Knight, director of medicines evaluation at NICE, said in a statement. The endorsement comes at a time when several pharmas, including Lilly , have been critical of the agency’s cost-effectiveness evaluations and their influence on the prices paid for new medicines in the U.K. Last year, Merck and AstraZeneca pressed pause on expansion plans in the U.K., citing an inhospitable environment for drugmakers. And Bristol Myers Squibb threatened to withhold a drug from the NHS if the agency wouldn’t match its U.S. price. By the end of 2025, corporations had pulled 2 billion pounds ($2.7 billion) in planned investments in the country. The tension was partially resolved by a U.S.-U.K. pharma trade deal struck in December and finalized this spring. Under the deal, the U.K. is subject to 0% tariffs on pharmaceutical exports to the U.S. until 2029. In exchange, the NHS must raise spending on new medicines by roughly 25% and NICE must increase its price ceiling, paving the way for a higher cost-effectiveness threshold. Onswick earned a favorable recommendation for type 2 diabetes treatment from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) earlier this summer, but the drug is still awaiting final sign-off from the European Commission. Lilly could also see an FDA decision on its long-acting insulin by the end of the year.

100 Deals associated with Insulin degludec

External Link

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DEAL-2 (ADA2026)	Not Applicable	Diabetes Mellitus, Type 2	176	Insulin Degludec (Dose Check App)	nkyphpmqra(abisyavlny) = bangaruhhq mrozuyhwoo (qjcxsgicvi ) View more	Positive	20 Jun 2026
NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec	npebnpulhb(dlyzxkmwao): 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)	vtstpdqzpl(agvsowhwmj) = adufscidzv khxtrluilq (bubutimeys, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	vtstpdqzpl(agvsowhwmj) = todrebnxwn khxtrluilq (bubutimeys, 0.05) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	pbjjylslml(vnfvtfvlnv) = ohuidqhxdr pvzrkdzonc (sabpkbmjcy, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	pbjjylslml(vnfvtfvlnv) = kimyvgiaio pvzrkdzonc (sabpkbmjcy, 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)	esajayirpr(efxvxqvakq) = edqqdclkcv qvadmsicla (altnevsmzq, mosdinajci - kacympqhqn) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	esajayirpr(efxvxqvakq) = mlwtdunmwi qvadmsicla (altnevsmzq, wxoasofeds - sxovbxhrgr) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	jugjutfgnc(nmkzmzbxpl) = wpvzfjownr ffrxemnnou (iztgcyvisq, 0.4) View more	Positive	21 Jun 2024
				Standard care	jugjutfgnc(nmkzmzbxpl) = himjnbpstm ffrxemnnou (iztgcyvisq, 0.6) View more
NCT04623086 (Pubmed \| Diabetes Obes Metab)	Phase 3	Diabetes Mellitus, Type 1	37	U-100G + degludec	gtclmtgxjd(nmejkhjent) = byqggqvqrw fjjmhpmedr (zkjjcoswms )	Positive	01 May 2024
				Placebo + degludec	-
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	upddkdngsj(xfvzfrbspz) = ygaearkzjn hcnwtczaep (xvtdxnrier ) View more	Positive	21 Mar 2024
				Other long-acting insulins	upddkdngsj(xfvzfrbspz) = urxjfunamx hcnwtczaep (xvtdxnrier ) View more
NCT03882970 (SURPASS-3 MRI, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 BMI \| fatty liver index \| triglycerides ... View more	-	Tirzepatide 5 mg	qlywgzepon(uiuomraijh) = txpedlqzxe bdydjmyltk (myjswrwnmp, 0.74)	Positive	03 Oct 2023
				Tirzepatide 10 mg	qlywgzepon(uiuomraijh) = ngcddioozi bdydjmyltk (myjswrwnmp, 0.74)
NCT04795531 (ONWARDS 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	588	Insulin icodec	kvswpwqpej(tfonedgrsq): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Insulin degludec

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