A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.

Start Date15 Apr 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06340854

/ CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Start Date19 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06288412

/ CompletedPhase 1

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Start Date26 Feb 2024

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Icodec Insulin

100 Translational Medicine associated with Icodec Insulin

100 Patents (Medical) associated with Icodec Insulin

104

Literatures (Medical) associated with Icodec Insulin

01 Jul 2025·Lancet Diabetes & Endocrinology

Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial

Article

Author: Terauchi, Yasuo ; Mathieu, Chantal ; Pagliaro Rocha, Thaís M ; Ramachandran, Ambady ; Ji, Linong ; Larsen, Jonas Hughes ; Shankarappa, Vinay Babu ; Giorgino, Francesco ; Kim, Sin Gon ; Philis-Tsimikas, Athena

BACKGROUND:

IcoSema is a once‑weekly combination therapy of basal insulin icodec (icodec) and semaglutide (a GLP‑1 analogue) currently in development. COMBINE 1 compared the efficacy and safety of IcoSema with once‑weekly icodec alone in adults with inadequately controlled type 2 diabetes on daily basal insulin therapy.

METHODS:

COMBINE 1, a 52‑week, open‑label, treat‑to‑target, randomised, phase 3a trial, was done at 192 outpatient clinics and hospital departments across 20 countries and regions. Individuals aged 18 years or older with a BMI of 40 kg/m² or less and type 2 diabetes (HbA_1c 7·0-10·0% [53·0-85·8 mmol/mol]) treated with daily basal insulin with or without oral glucose‑lowering medications were randomly assigned (1:1) via a randomisation and trial supply management system to IcoSema (700 U/mL plus 2 mg/mL) or icodec (700 U/mL), both administered as subcutaneous injections on the same day each week, at any time of the day. There was no stratification based on participants' baseline characteristics. The primary endpoint was change in HbA_1c from baseline to week 52, evaluated in the full analysis set (all randomly assigned participants). The trial is registered with ClinicalTrials.gov, NCT05352815, and has been completed.

FINDINGS:

Between June 1, 2022, and March 13, 2023, 1671 individuals were screened, of whom 1291 (mean age 60·6 years [SD 10·3]; 799 [62%] males and 492 [38%] females) were randomly assigned to IcoSema (n=646) or icodec (n=645). At week 52, from a baseline value of 8·22% (SD 0·83; 66·3 mmol/mol [9·1]), estimated mean change in HbA_1c was -1·55 percentage points (SE 0·03; -16·9 mmol/mol [0·4]) with IcoSema and -0·89 percentage points (SE 0·03]; -9·7 mmol/mol [0·4]) with icodec (estimated treatment difference [ETD] -0·66 percentages points [95% CI -0·76 to -0·57]; -7·3 mmol/mol [-8·3 to -6·2]; p<0·0001; superiority confirmed). The rate of combined clinically significant or severe hypoglycaemia from baseline to week 57 was significantly lower with IcoSema than with icodec (0·14 vs 0·63 episodes per person‑year of exposure; estimated rate ratio 0·22 [95% CI 0·14 to 0·36]; p<0·0001; superiority confirmed). The most frequently reported adverse events were within the system organ class of gastrointestinal disorders in the IcoSema group (303 [47%] of 644 participants had 1033 events during the trial) and infections and infestations in the icodec group (275 [43%] of 644 participants had 466 events. 59 (9%) participants in the IcoSema group and 69 (11%) participants in the icodec group had a serious adverse event. No treatment-related deaths occurred.

INTERPRETATION:

In adults with inadequately controlled type 2 diabetes on daily basal insulin therapy, once‑weekly IcoSema showed superiority to once-weekly icodec alone in changes in HbA_1c and in overall lower rate of combined clinically significant or severe hypoglycaemia. IcoSema might provide an option for insulin therapy intensification in adults with type 2 diabetes.

FUNDING:

Novo Nordisk.

TRANSLATIONS:

For the Chinese and Japanese translations of the abstract see Supplementary Materials section.

01 Jul 2025·DIABETOLOGIA

The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1–5

Article

Author: Heller, Simon ; Woo, Vincent C ; Riddell, Michael C ; Kehlet Watt, Sara ; Carstensen, Lisbeth ; Rocha, Thaís M Pagliaro

Abstract:

Aims/hypothesis:

Physical activity increases the risk of hypoglycaemia in individuals with type 2 diabetes when basal or basal-bolus insulin therapy is administered. Once-weekly basal insulins may elevate the risk of physical activity-attributed hypoglycaemia compared with other basal insulins because the administered levels cannot be reduced in anticipation of increased physical activity. This post hoc analysis of five separate randomised trials (ONWARDS 1–5) aimed to examine physical activity-attributed hypoglycaemic episodes in adults with type 2 diabetes receiving either once-weekly basal insulin icodec (herein referred to as ‘icodec’) or once-daily basal insulins.

Methods:

The ONWARDS 1–5 Phase 3a randomised controlled trials compared the efficacy and safety of once-weekly basal icodec vs once-daily basal insulin in insulin-naive (ONWARDS 1, 3 and 5) and insulin-experienced (ONWARDS 2 and 4) adults with type 2 diabetes. Participants self-monitored their blood glucose levels using a blood glucose meter and a digital diary. In each trial, suspected hypoglycaemia symptoms triggered additional self-measured blood glucose readings, and values indicative of hypoglycaemia were recorded in the participants’ digital diary. Participants who experienced hypoglycaemic episodes were instructed to note any relation of each episode to physical activity. Hypoglycaemic episodes were classified as alert value (level 1: blood glucose <3.9 but ≥3.0 mmol/l), clinically significant (level 2: blood glucose <3.0 mmol/l) or severe (level 3: cognitive impairment requiring external assistance). The proportions of hypoglycaemic episodes that were attributed to physical activity and the ORs of having a physical activity-attributed hypoglycaemic episode were calculated for the two basal insulin types (once-weekly vs once-daily) for each of the five trials.

Results:

Across all trials, there were no consistent differences between icodec and the once-daily insulin comparators in the proportions of hypoglycaemic episodes that were attributed to physical activity; these episodes were mainly alert value or clinically significant hypoglycaemic episodes. In both insulin-naive and insulin-experienced participants, the incidence of physical activity-attributed clinically significant or severe hypoglycaemic episodes was consistently ≤3.0% in ONWARDS 1, 2, 3 and 5. In ONWARDS 4, the incidence of physical activity-attributed hypoglycaemic episodes was numerically higher in both treatment groups (18.6% [icodec] vs 17.9% [insulin glargine U100]), which was expected given the basal-bolus insulin regimen. Across all trials, there were no statistically significant differences in the odds of experiencing a physical activity-attributed clinically significant or severe hypoglycaemic episode with icodec vs once-daily insulin comparators. The frequency of recurrent clinically significant or severe hypoglycaemic episodes in the 24 h after a physical activity-attributed clinically significant or severe hypoglycaemic episode was low, with no such episodes in ONWARDS 1, 3 and 5. In contrast, in ONWARDS 2 and 4, the frequency of recurrent clinically significant hypoglycaemic episodes in the 24 h after a physical activity-attributed clinically significant or severe hypoglycaemic episode was numerically higher with icodec vs the once-daily insulin comparators, whilst no additional severe episodes were reported in any participants across the trials.

Conclusions/interpretation:

These findings do not suggest that there is an additional increase in hypoglycaemia risk attributed to physical activity with once-weekly basal icodec vs once-daily basal insulins in adults with type 2 diabetes.

Trial registration:

ClinicalTrials.gov NCT04460885 (ONWARDS 1), NCT04770532 (ONWARDS 2), NCT04795531 (ONWARDS 3), NCT04880850 (ONWARDS 4) and NCT04760626 (ONWARDS 5).

Graphical Abstract:

01 Jun 2025·ANNALS OF PHARMACOTHERAPY

Icodec: A Novel Once-Weekly Basal Insulin for Diabetes Management

Review

Author: Isaacs, Diana ; Goldman, Jennifer ; Triplitt, Curtis

Objective::

To evaluate the efficacy, safety, and clinical implications of insulin icodec, a novel once-weekly basal insulin for the treatment of type 1 diabetes (T1D) and type 2 diabetes (T2D), with an emphasis on its advantages and challenges in comparison with existing daily basal insulins.

Data Sources::

A literature search was performed using PubMed, Google Scholar, Embase, and ClinicalTrials.gov up to August 26, 2024, using the search terms icodec and ONWARDS trial . Studies involving patients living with T1D or T2D on once-weekly insulin icodec compared with once-daily insulins glargine U100, glargine U300, and degludec were considered for this review.

Study Selection and Data Extraction::

Relevant English-language studies and those conducted in humans were considered.

Data Synthesis::

Insulin icodec offers reduced dosing frequency and potentially superior glycemic management with a safety profile comparable to existing basal insulins.

Relevance to Patient Care and Clinical Practice::

Insulin icodec once-weekly dosing could significantly improve convenience and efficacy over daily basal insulins, representing a significant innovation in insulin therapy.

Conclusions::

Insulin icodec emerges as a promising option for diabetes management, potentially improving treatment adherence and quality of life.

News (Medical) associated with Icodec Insulin

23 Jun 2025

·www.fiercepharma.com

Lilly eyes global approval filings as once-weekly insulin candidate takes clinical victory lap

Eli Lilly says it plans to take its efsitora data package to global regulatory agencies by the end of this year. With detailed readouts from a suite of late-stage trials now on tap, Eli Lilly is heading to regulators in pursuit of a green light for its once-a-week insulin asset efsitora alfa.Lilly on Sunday provided a comprehensive look at positive results from its QWINT-1, QWINT-3 and QWINT-4 studies, which assessed efsitora in Type 2 diabetes patients using insulin for the first time, those who previously used daily basal insulin and those who previously used daily basal insulin and mealtime insulin, respectively.Efsitora—which would allow diabetes patients to cut back on more than 300 insulin injections per year if approved—helped patients achieve noninferior A1C (blood sugar) reduction versus daily basal insulin in all three studies, helping the clutch of trials meet their primary endpoints, Lilly said.With those winning results in hand, Lilly says it plans to take its efsitora data package to global regulatory agencies by the end of this year. Overall, Lilly has unveiled positive readouts from five different trials in the QWINT program, which kicked off in 2022.The momentum behind efsitora comes as Lilly’s chief metabolic medicine rival Novo Nordisk has struggled to win clearance for its own once-weekly insulin in the U.S. That said, Novo’s drug, known commercially as Awiqli, already boasts approvals in territories like Europe, Canada, Japan and Australia. Breaking down the results, efsitora helped reduce patients’ A1C by 1.31% versus 1.27% for insulin glargine at the QWINT-1 study’s 52-week mark. In QWINT-3, efsitora reduced A1C by 0.86% at Week 26 and in QWINT-4 by 1.07% over the same time frame, compared to 0.75% for insulin degludec and 1.07% for insulin glargine, respectively.Lilly also unveiled results from several key secondary endpoints in QWINT-3 and 4. In the former trial, efsitora patients’ glucose levels were in range 62.8% of the time during the four weeks leading up to Week 26 of the study, compared to 61.3% of the time for those on insulin degludec.In QWINT-4, meanwhile, efsitora helped 39.5% of patients achieve an A1C less than 7% at Week 26 without nocturnal hypoglycemia, compared to 36.6% of patients receiving insulin glargine.For QWINT-1, Lilly says it titrated efsitora to four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3 and 4, efsitora was given via traditional insulin dosing with adjustments according to each patient’s glucose level, the company explained.Efsitora’s safety in the three studies was on par with insulin glargine and insulin degludec, which are among the most commonly used daily basal insulins, Lilly noted in its release.In the QWINT-1 study, patients on efsitora experienced roughly 40% fewer hypoglycemic events—when a person’s blood sugar drops too low—compared to insulin glargine, Lilly pointed out.Meanwhile, at the QWINT-1 study’s 52-week mark, the estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure was 0.50 with efsitora versus 0.88 with insulin glargine. For QWINT-3, those results clocked in at 0.84 with efsitora versus 0.74 with insulin degludec at 78 weeks, while the QWINT-4 results came in at 6.6 with efsitora versus 5.9 with insulin glargine at 26 weeks."Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Jeff Emmick, M.D., Ph.D., Lilly’s senior vice president of product development, said in a statement. "These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach”Across the QWINT program, Lilly has looked at efsitora’s performance in more than 3,000 Type 2 diabetes patients. QWINT-1 enrolled 795 participants versus 986 for QWINT-3 and 730 for QWINT-4.Lilly presented the latest trio of readouts over the weekend at the 85th American Diabetes Association Scientific Sessions in Chicago. The results from QWINT-1 were also published in The New England Journal of Medicine, while data from QWINT-3 and 4 have made their way into The Lancet, according to Lilly.The detailed look at QWINT-1, 3 and 4 follows a succession of positive readouts from the program since last May, when Lilly first revealed that the QWINT-2 and 4 studies had met their A1C noninferiority endpoints. QWINT-2 was specifically designed to assess whether the use of GLP-1 medicines for diabetes like Mounjaro or Novo’s Ozempic could weigh on efsitora’s efficacy.Lilly is betting big on efsitora’s potential to both improve treatment for patients already using daily insulin and encourage new patients to start using the medication.“Imagine 313 fewer injections per year,” Paul Owens, VP of global brand development for insulins and glucagon at Lilly, said of the drug’s promise in an interview with Fierce Biotech last year. “We believe it has the potential to really improve adherence … and for some, the innovation of a simple, once-weekly approach to dosing could really mean the difference between starting the treatment and not.”Diabetes patients have been grappling with daily insulin dosing for nearly a century, and those repetitive injections in response to blood glucose tests can become a “huge burden” for people living with the disease, Owens said at the time.Though Novo Nordisk beat Lilly to the punch launching its weekly insulin product Awiqli overseas, Lilly now appears poised to take the lead in the U.S. Last July, the FDA rejected Novo’s application for the product, which is also known as insulin icodec. Novo credited the rejection to “requests related to the manufacturing process and the type 1 diabetes indication.” At the time, Novo cautioned that it didn’t expect to resolve the issue by the end of 2024.The snub followed an unfavorable vote from an FDA advisory committee, which largely revolved around questions about icodec’s potential to cause low blood sugar.Ultimately, seven of 11 panelists agreed that the data Novo presented were not sufficient to conclude that the benefits of icodec outweighed the risks for adults with Type 1 diabetes.

Clinical Result

23 Jun 2025

·pharma.economictimes.indiatimes.com

Lilly’s once-weekly insulin matches daily doses in efficacy across multiple trials

New Delhi: Eli Lilly ’s once-weekly type 2 diabetes insulin, efsitora alfa , has shown efficacy and safety results comparable to daily insulin across multiple Phase 3 trials . Announcing results from the three Phase 3 trials — QWINT-1, QWINT-3, and QWINT-4 — the company said: “In each trial, efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin.” The late-stage studies evaluated the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes, across different treatment histories: first-time insulin users, prior daily basal insulin users, and users of both daily basal and mealtime insulin. Across the three studies, the investigational candidate reported greater A1C reduction compared to insulin glargine (at both 52 and 26 weeks) and degludec (at 26 weeks), along with 40 per cent fewer hypoglycemic events versus glargine. In the QWINT-1 trial, efsitora was titrated to four fixed doses at four-week intervals, while in the other two trials, dosing was adjusted using traditional insulin titration based on each patient's glucose levels. Complete results from the studies were presented at the ADA 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1 — the first fixed-dose study of its kind — were published in The New England Journal of Medicine, while QWINT-3 and QWINT-4 results appeared in The Lancet. “Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year. These results reinforce the potential to reduce the overall burden of insulin therapy through a simplified treatment approach,” said Jeff Emmick, Senior Vice President of Product Development, Eli Lilly. Lilly plans to submit efsitora for approval for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year, the company said in a release. Efsitora alfa combines a novel single-chain variant of insulin with a human IgG2 Fc domain, and is designed to provide more stable glucose levels with less variability throughout the week. Currently, Danish drugmaker Novo Nordisk has a once-weekly basal insulin — insulin icodec — marketed under the brand name Awiqli. By Online Bureau ,

Clinical ResultPhase 3Drug Approval

23 Jun 2025

·pharma.economictimes.indiatimes.com

Lilly’s once-weekly insulin matches daily doses in efficacy across multiple trials

Clinical ResultPhase 3Drug Approval

100 Deals associated with Icodec Insulin

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	European Union	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Iceland	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Liechtenstein	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus	Norway	Novo Nordisk A/S	17 May 2024
Diabetes Mellitus, Type 1	Canada	Novo Nordisk Canada, Inc.	12 Mar 2024
Diabetes Mellitus, Type 2	Canada	Novo Nordisk Canada, Inc.	12 Mar 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04460885 (ONWARDS 1, CTgov)	Phase 3	Diabetes Mellitus, Type 2	984	Insulin icodec (Insulin Icodec)	konitueppj(hwgpbtqyek) = qwtuwywxem ddizqfwfnv (fzrltomhgh, 0.06) View more	-	12 Jun 2025
				Insulin glargine (Insulin Glargine)	konitueppj(hwgpbtqyek) = ggvqztrxlb ddizqfwfnv (fzrltomhgh, 0.05) View more
NCT04848480 (ONWARDS 6, CTgov)	Phase 3	Diabetes Mellitus, Type 1	582	insulin icodec+insulin aspart (Insulin Icodec + Insulin Aspart)	xxpurdgeso(ftzjjqbxai) = gpbsmyrheu ktnvupqnkt (lvkctnwtob, 0.07) View more	-	12 Jun 2025
				insulin degludec+insulin aspart (Insulin Degludec + Insulin Aspart)	xxpurdgeso(ftzjjqbxai) = pcwlfzcvxi ktnvupqnkt (lvkctnwtob, 0.06) View more
ONWARDS 1-6 (Pubmed \| Diabetes Ther)	Phase 3	-	-	Icodec	wekbhwwjxg(mzjusalotc) = Mean HbA1c levels remained relatively stable over assessed time points for both treatment groups rakpnmvlrl (rvrrynfzll ) View more	Positive	04 Jun 2025
				Once-daily comparators (insulin degludec, insulin glargine U100, insulin glargine U300)
NCT05823948 (ONWARDS 9, Pubmed \| Diabetes Technol Ther) Manual	Phase 3	Diabetes Mellitus, Type 2	51	Once-weekly Insulin Icodec	pddbjqbdmv(fsguqjwkwn) = arbcypoxxd uxhhaqdyzq (pkczthikac, -1.36 to -0.99)	Positive	05 Mar 2025
NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	-	Once-Weekly Insulin Icodec	yljcoxkzel(bqzrfnzapg): P-Value = 0.0152	Positive	28 Feb 2025
				Once-Daily Insulin Degludec
NCT04770532 (ONWARDS 2, CTgov)	Phase 3	Diabetes Mellitus, Type 2	526	Insulin Icodec (Insulin Icodec)	ytuxqehyda(naobzmtotc) = mpzvgajmzb qxneslgvmc (lbkzllejez, 0.05) View more	-	20 Feb 2025
				Insulin Degludec (Insulin Degludec)	ytuxqehyda(naobzmtotc) = prkvkxbemr qxneslgvmc (lbkzllejez, 0.06) View more
NCT04795531 (ONWARDS 3, CTgov)	Phase 3	Diabetes Mellitus, Type 2	588	placebo+insulin icodec (Insulin Icodec)	lozzjcxjvd(hvfjohzvam) = zicniutshs fhxbzcgjkr (jygoefacoc, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	lozzjcxjvd(hvfjohzvam) = obndsndjrv fhxbzcgjkr (jygoefacoc, 0.05) View more
PROSPERO CRD42023452468 (ENDO2024)	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin Icodec	ptoprrgepr(factsfthlb) = faquzunwfs vylneskrpd (ykcjohqeew, 0.42 - 1.15) View more	Positive	01 Jun 2024
NCT04880850 \| NCT04770532 (ONWARDS 4 \| ONWARDS 2, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	-	Once-weekly icodec	tnmqxjjllb(abwhucwkae) = tekdgzwbzm ifsrqtdkid (tzqezyskzs )	Positive	04 Oct 2023
				Once-daily degludec	tnmqxjjllb(abwhucwkae) = bszvxxvhgy ifsrqtdkid (tzqezyskzs )
NCT04760626 (ONWARDS 5, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	-	Once-weekly insulin icodec with a dosing guide app	wcldyolgnl(fzjcbedbdz): P-Value = <0.0001 View more	Positive	03 Oct 2023
				Once-daily basal insulin analogues (degludec, glargine U100 or glargine U300)

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