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

/ SuspendedPhase 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

957

Literatures (Medical) associated with Insulin degludec

01 Mar 2026·DIABETES OBESITY & METABOLISM

Efficacy and safety of switching basal insulin to insulin glargine 300 U/ mL in individuals with inadequately controlled type 2 diabetes on advanced insulin therapies: The Toujeo‐Neo T2DM study

Article

Author: Pfohl, Martin ; Han, Henry Y. ; Fritsche, Andreas ; Anderten, Helmut ; Pscherer, Stefan ; Pegelow, Katrin ; Seufert, Jochen

Abstract:

Aims:

This real‐world study evaluated the effectiveness and safety of switching basal insulin (BI) to insulin glargine 300 U/mL (Gla‐300) in adults with inadequately controlled type 2 diabetes mellitus (T2DM), previously receiving basal‐supported oral therapy plus prandial insulin (BOTplus) or multiple (≥3) daily injections (MDI) of short‐acting insulins.

Materials and Methods:

This non‐interventional, multicentre, open‐label, prospective 12‐month study in Germany included adult participants (≥18 years) with T2DM, HbA 1c between 7.5% and 10.0%, and fasting plasma glucose (FPG) >130 mg/dL (>7.2 mmol/L). The participants were switched from non‐Gla‐300 BOTplus or MDI regimen (including Gla‐100, IDet, IDeg, or NPH) to Gla‐300. The primary endpoint was the duration of glycaemic target achievement, defined as the time between ≥2 FPG values ≤110 mg/dL (≤6.1 mmol/L) or ≥1HbA 1c value below the predefined target.

Results:

Of 1217 participants, 582 completed the documentation of the 12‐month Gla‐300 treatment (FAS2‐M12). Target achievement with Gla‐300 was reported for 280/582 FAS2‐M12 participants (48.1%). The median response duration was 295 days (95% CI: 226, 381). The mean (±SD) change in HbA 1c and FPG from baseline was −0.56% (±1.08; n = 568) and −29.3 mg/dL or 1.63 mmol/L (±54.95; n = 540) at month 12, respectively ( p < 0.0001). Numbers and incidence of hypoglycaemia were similar before starting Gla‐300 therapy and at month 12. Body weight (100.1 kg ± 21.07; n = 571 at baseline) remained unchanged until month 12 (mean change: −0.0 kg ± 8.40; n = 513).

Conclusions:

Switching BI to Gla‐300 from a BOTplus or MDI regimen with prior insulin Gla‐100, IDeg, IDet, or NPH improved glycaemic control in participants with inadequately controlled T2DM over 12 months without increasing hypoglycaemia risk or weight gain.

01 Mar 2026·DIABETES OBESITY & METABOLISM

Once‐weekly insulin icodec versus once‐daily insulin degludec for type 2 diabetes in China: A cost‐utility and budget impact analysis

Article

Author: Zhang, Yawen ; Tong, Xichen ; Zhang, Lei ; Zhang, Luying

Abstract:

Aims:

Insulin icodec, the first once‐weekly basal insulin analogue, was approved in China in 2024. Although it has demonstrated robust clinical efficacy, its budget impact remains unknown, and the long‐term cost‐utility within the reimbursement context needs further estimates. This study evaluated the long‐term cost‐utility of once‐weekly insulin icodec compared with once‐daily insulin degludec in China.

Materials and methods:

We used the validated IHE Diabetes Cohort Model to simulate lifetime costs and health outcomes for insulin‐naive Chinese patients with type 2 diabetes, based on the Chinese subgroup of the ONWARDS 3 trial. The model incorporated diabetes‐related microvascular and macrovascular complications, with a 40‐year time horizon and 5% annual discount rate. Costs and utilities were derived from the 2024 national reimbursement drug list, the national insulin volume‐based procurement policy, and published literature, expressed in 2024 US dollars. Analyses were conducted from the Chinese healthcare system perspective. Robustness was assessed through one‐way and probabilistic sensitivity analyses. A complementary budget impact analysis (BIA) estimated national‐level financial implications under different reimbursement scenarios.

Results:

Compared with degludec, icodec increased life expectancy by 0.025 years and yielded a gain of 0.216 quality‐adjusted life‐years (QALYs), while reducing costs by $1450.73. One‐way sensitivity analyses showed incremental QALYs ranging from 0.065 to 0.464 and cost savings from $ 265.84 to $4166.30. Probabilistic sensitivity analysis confirmed mean gains of 0.212 QALYs and cost reductions of $1320.46. The BIA estimates estimated annual savings of $1.17 million, $2.35 million, and $2.58 million in 2025, 2026, and 2027, following the reimbursement of icodec.

Conclusions:

Within the current reimbursement context in China, once‐weekly icodec is a dominant strategy compared with degludec, offering greater health benefits at a lower cost for patients with type 2 diabetes and generating potential annual savings.

01 Mar 2026·CLINICAL PHARMACOKINETICS

Population Pharmacokinetic and Pharmacodynamic Modeling to Support Molar Dose Ratio Determination of Long-Acting Insulin Analogs

Article

Author: Li, Xiaojuan ; Zhu, Min ; Yu, Xiaoling ; Zhang, Xiaoli ; Gao, Xuehu ; Tang, Dan ; Feng, Sheng ; Shu, Chang ; Chen, Hong ; Dong, Yanli ; Cai, Daren

BACKGROUND AND OBJECTIVE:

INS068 is a new soluble, long-acting insulin analog intended to cover basal insulin requirements in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). The purpose of this study was to determine the molar dose ratio of INS068 to insulin degludec (IDeg) by comparing the clinical pharmacokinetic (PK) and pharmacodynamic (PD) profiles of INS068 and IDeg. The PD endpoints include glucose infusion rate (GIR) and glycated hemoglobin (HbA1c).

METHOD:

Population pharmacokinetic and pharmacodynamic (PopPK/PD) analysis was performed to characterize INS068 and IDeg PK and PD profiles. Data from 307 subjects across three Phase I studies and one Phase II study were used to establish the population pharmacokinetic (PopPK) model, of which two euglycemic clamp (Phase I) studies were used to establish PopPK-GIR model, and one Phase II study was used to establish PopPK-HbA1c model. Nonlinear mixed-effects modeling was used to investigate the PK and PD relationships of INS068 and IDeg. Model-based simulations were performed to determine the molar dose ratio of INS068 to IDeg.

RESULTS:

The PopPK model of INS068 and IDeg was described by a one-compartment model with linear absorption with a lag time and elimination. Significant covariate effects of body weight, population, and treatment (INS068 vs IDeg) were identified for PK parameters of INS068 and IDeg. However, except for body weight and T2DM patients, the other significant covariates (treatment and T1DM patients) had no clinically relevant effects on PK exposures. The relationship between GIR and insulin concentrations in effect compartment was described by a direct response model with sigmoidal E_max drug effect. The relationship between insulin concentration and HbA1c was well described by an indirect response model. The covariate analysis of the PopPK-GIR and PopPK-HbA1c models showed that treatment (INS068 vs IDeg) had no significant impact on the PD parameters. The results of model-based simulation demonstrated that the PK and PD of INS068 and IDeg were comparable.

CONCLUSION:

This analysis supported molar dose ratio of INS068 to IDeg as 1. INS068 had similar potency compared to IDeg, with one unit of INS068 composed of 6 nmol of active ingredient (1 U = 6 nmol).

News (Medical) associated with Insulin degludec

01 Apr 2026

·allsci.com

Gan & Lee’s once-weekly basal insulin beats insulin glargine and degludec in Phase III type 2 diabetes trials

Gan & Lee Pharmaceuticals (SSE: 603087) reported that its investigational once-weekly basal insulin analog, GZR4, met the primary endpoint of superior HbA1c reduction versus both insulin glargine U100 (Lantus) and insulin degludec (Tresiba) across two pivotal Phase III trials in adults with type 2 diabetes, positioning the molecule as a direct challenger to Novo Nordisk’s recently FDA-approved insulin icodec (Awiqli). The SUPER-1 and SUPER-2 trials are active-controlled, treat-to-target Phase III studies enrolling 588 insulin-naïve and 631 basal-insulin-experienced Chinese adults with type 2 diabetes, respectively, conducted across more than 80 medical centers in China. In SUPER-1, the estimated mean HbA1c change from baseline at 26 weeks was -1.45% with GZR4 versus -1.22% with glargine U100, a between-group difference of -0.23%. In SUPER-2, GZR4 produced a -1.00% reduction compared with -0.58% for degludec, a difference of -0.42%. Both trials also showed GZR4 achieved a higher rate of the composite endpoint of HbA1c below 7.0% or at or below 6.5% without clinically significant or severe hypoglycemia. No severe (Level 3) hypoglycemic events occurred in either treatment group across both trials. GZR4 is an ultra-long-acting basal insulin analog engineered to provide full-week basal insulin coverage from a single subcutaneous injection, without requiring a loading dose. The absence of a loading dose distinguishes it from Awiqli, which requires a double maintenance dose in the first week to reach steady-state rapidly. The SUPER program describes a greater than 85% reduction in annual injection frequency compared with once-daily regimens — from approximately 365 injections per year to 52. The competitive context is acute. Novo Nordisk’s Awiqli received FDA approval for adults with type 2 diabetes on March 26, 2026 — five days before Gan & Lee released the SUPER-1 and SUPER-2 top-line data. Awiqli, which uses albumin binding to extend its half-life to approximately 196 hours, is now the only approved once-weekly basal insulin in the US market. GZR4 enters that comparison as an investigational molecule with Phase III superiority data versus daily analogs, but without head-to-head data against icodec yet available. That comparison is the subject of SUPER-8, a 26-week trial enrolling 300 patients with type 2 diabetes previously treated with basal insulin, with results expected within the next 12 months. Cross-trial comparisons are limited by differences in patient populations, titration algorithms, and background therapies. The magnitude of HbA1c separation in SUPER-2 — 0.42 percentage points versus degludec — is notable within the context of basal insulin trials, where active comparators are themselves well-optimized agents. The SUPER-1 difference of 0.23 percentage points versus glargine U100 is more modest, though both results met pre-specified superiority thresholds. Full statistical outputs, including confidence intervals and p-values, have not yet been disclosed; detailed results are planned for presentation at a scientific conference and peer-reviewed publication. The trials enrolled exclusively Chinese adults, which will be relevant to any regulatory filing strategy outside China. The SUPER program is described as a global Phase III development program, though the four currently initiated trials are all China-based. Whether Gan & Lee pursues regulatory submissions in the US or EU, and whether additional international trials are planned, was not addressed in the top-line release. Gan & Lee also has two additional SUPER trials underway: SUPER-3, enrolling 580 patients on basal-bolus therapy, comparing GZR4 against glargine U100 in combination with insulin aspart; and SUPER-8, the icodec head-to-head. The full dataset from all four trials will determine the breadth of the clinical package available for any regulatory submission. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at a scientific conference later in 2026, with peer-reviewed publication to follow. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultDrug ApprovalPhase 2NDA

31 Mar 2026

·www.prnewswire.com

Gan & Lee Pharmaceuticals' Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2

BEIJING and BRIDGEWATER, N.J., March 31, 2026 /PRNewswire/ -- Gan & Lee Pharmaceuticals (SSE: 603087) today announced that two pivotal phase 3 clinical trials, SUPER-1 and SUPER-2, evaluating investigative once-weekly insulin GZR4 Injection, have successfully met their pre-specified primary endpoints. After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c)* compared with once-daily insulin glargine U100 (Lantus®) and once-daily insulin degludec (Tresiba®). SUPER-1: Trial in Insulin-Naïve Patients with Type 2 Diabetes Mellitus SUPER-1 is a 52-week (26-week main phase plus 26-week extension phase), phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment, in 588 insulin-naïve Chinese adults with type 2 diabetes mellitus (T2DM) across 84 medical sites in China (ClinicalTrials.gov Identifier: NCT06767735). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin glargine U100: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.45% in the GZR4 group versus -1.22% in the insulin glargine U100 group, with a statistically significant estimated between-group treatment difference of -0.23%. GZR4 also achieved a significantly higher rate of safe glycemic target attainment: the treatment group outperformed the insulin glargine U100 group on the clinically relevant composite endpoint of achieving HbA1c <7.0% or ≤6.5% without experiencing clinically significant (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. SUPER-2: Trial in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal Insulin SUPER-2 is a 26-week, phase 3, treat-to-target trial investigating the efficacy and safety of once-weekly GZR4 versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment, in 631 Chinese adult patients with T2DM previously treated with basal insulin across 82 medical centers in China (ClinicalTrials.gov Identifier: NCT06767748). The trial met its primary endpoint. GZR4 demonstrated statistically significant superiority in HbA1c reduction versus insulin degludec: after 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.00% in the GZR4 group versus -0.58% in the insulin degludec group, a statistically significant estimated between-group treatment difference of -0.42%. GZR4 also delivered a significantly higher rate of safe glycemic target attainment, outperforming the insulin degludec group on the composite endpoint of achieving HbA1c <7.0% or ≤6.5% without clinically meaningful (Level 2) or severe (Level 3) hypoglycemia. Once-weekly GZR4 demonstrated a favorable safety and tolerability profile. No severe (Level 3) hypoglycemic events occurred in either treatment group. Detailed results from SUPER-1 and SUPER-2 are planned for presentation at this year's scientific conference and will be submitted for publication in peer-reviewed international academic journals. Additional findings from the GZR4 Injection's ongoing clinical program are expected to be released over the following 12 months. *Glycated hemoglobin A1c (HbA1c): A biomarker that reflects average blood glucose levels over the preceding 2 to 3 months and is the gold-standard endpoint for evaluating the efficacy of anti-diabetic treatment. The above data are derived from the modified Intention-to-treat (mITT) Set and Safety Set (SS) under the treatment policy. Dr. Chen Wei from Gan & Lee Pharmaceuticals remarked: "We are thrilled to report positive top-line results from the SUPER-1 and SUPER-2 trials. This robust dataset confirms that GZR4 delivers statistically significant superiority over the active comparators on the primary endpoint of HbA1c reduction, with an overall safety profile closely aligned with that of marketed once-daily basal insulins. These findings position GZR4 as a promising, enhanced option for patients with T2DM who require basal insulin therapy. As a novel once-weekly insulin, GZR4 Injection has demonstrated compelling best-in-class potential. The SUPER phase 3 pivotal clinical program includes four randomized, active-controlled, treat-to-target trials conducted across China in approximately 2,120 adults with inadequately controlled T2DM, to deliver a systematic evaluation of the efficacy and safety of once-weekly GZR4 versus once-daily basal insulins. Compared with once-daily formulations, once-weekly GZR4 delivers a more than 85% reduction in annual injection frequency, with no need for an additional loading dose. This simplified regimen is engineered to improve treatment adherence, optimize long-term glycemic control, and drive meaningful, sustained improvements in the quality of life for people living with diabetes. At a time when industry players are scaling back investment in insulin research and development, Gan & Lee Pharmaceuticals is accelerating the development of GZR4. This progress fully embodies our unwavering commitment to pioneering innovation in diabetes care, and our steadfast dedication to safeguarding patient health." About the SUPER Clinical Program The SUPER program is a large-scale global phase 3 clinical development program for GZR4 Injection, a proposed once-weekly basal insulin by Gan & Lee. To date, four phase 3 clinical trials have been initiated in China: SUPER-1: A 52-week trial enrolling 588 insulin-naïve adults with T2DM, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment. SUPER-2: A 26-week trial enrolling 631 adults with T2DM previously treated with basal insulin, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment. SUPER-3: A 26-week trial enrolling 580 patients with T2DM previously treated with basal-bolus insulin therapy, comparing the efficacy and safety of once-weekly GZR4 Injection versus once-daily insulin glargine U100 (Lantus®) in combination with insulin aspart, with or without concomitant non-insulin anti-diabetic treatment. SUPER-8: A 26-week trial enrolling 300 patients with T2DM previously treated with basal insulin, comparing the efficacy and safety of GZR4 Injection versus insulin icodec (Awiqili®), with or without concomitant non-insulin anti-diabetic treatment. About GZR4 Injection GZR4 Injection is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals to cover the basal insulin requirements for a full week with a single subcutaneous injection. GZR4 Injection is designed to help people with diabetes overcome barriers to injection, initiate and sustain insulin therapy earlier, optimize long-term diabetes management, and improve quality of life. Completed phase 3 clinical trial results show that once-weekly GZR4 Injection is superior to once-daily insulin glargine U100 and insulin degludec in reducing HbA1c levels in adult patients with T2DM. The global clinical development of GZR4 Injection is currently in the phase 3 stage. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. SOURCE Gan & Lee Pharmaceuticals 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 2

30 Mar 2026

·allsci.com

FDA approves Novo Nordisk’s Awiqli, the first once-weekly basal insulin for type 2 diabetes

The US FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, developed by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The decision makes Awiqli the first and only once-weekly basal insulin approved by the US FDA, reducing the injection frequency from seven times per week to one. It is also the first change to basal insulin dosing frequency in more than two decades, since the introduction of once-daily long-acting analogs such as insulin glargine around the year 2000. Awiqli is already approved in the EU and 13 additional countries. The approval covers use of the weekly insulin in combination with mealtime insulin or with common oral anti-diabetic agents and GLP-1 receptor agonists. It is administered via the Awiqli FlexTouch pen on the same day each week. The product is not approved for use in children or adolescents. Novo Nordisk said Awiqli will be available nationwide in the US in the coming months. The insulin icodec FDA approval is supported by the ONWARDS Phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials enrolling approximately 2,680 adults with uncontrolled type 2 diabetes. These trials evaluated once-weekly Awiqli against daily basal insulins, including insulin glargine U-100 (ONWARDS 1) and insulin degludec (ONWARDS 2, ONWARDS 3), across both insulin-naive patients and those switching from daily basal or basal-bolus regimens (ONWARDS 4). The primary endpoint across the program was reduction of HbA1c, and the company reported that Awiqli demonstrated efficacy on this measure. The safety profile was described as consistent with the daily basal insulin class. Common adverse events included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, peripheral edema, and weight gain. The approval of Novo Nordisk insulin icodec addresses a long-recognized gap in type 2 diabetes management. Despite the availability of effective daily basal insulins, adherence remains a persistent challenge. Injection fatigue, missed doses, and what clinicians term “psychological insulin resistance” — reluctance among patients and providers to initiate insulin therapy — contribute to suboptimal glycemic control in a substantial proportion of the estimated 37 million Americans living with type 2 diabetes. Research has indicated that weekly injectable diabetes medications may be associated with improved adherence, and Awiqli’s once-weekly dosing is designed to reduce the burden that daily injections impose. The weekly insulin for type 2 diabetes enters a treatment landscape that has been reshaped in recent years by the arrival of GLP-1 receptor agonists such as semaglutide and dual GIP/GLP-1 agonists such as tirzepatide, both of which offer HbA1c reduction alongside weight loss and cardiovascular benefits. Awiqli occupies a distinct niche as a basal insulin rather than an incretin-based therapy, targeting patients who require insulin but may benefit from a less frequent dosing schedule. Eli Lilly is developing insulin efsitora alfa, another once-weekly basal insulin currently in late-stage clinical development, which would make this a directly competitive space if approved. For Novo Nordisk, securing the first-mover position with Awiqli adds to a diabetes portfolio that already includes insulin degludec (Tresiba), insulin aspart (NovoLog), and the combination product Xultophy. The approval does not resolve all unmet needs in basal insulin therapy. Hypoglycemia risk remains present, weight gain is listed among common side effects, and the US approval does not include type 1 diabetes. Whether the reduction in injection frequency translates into measurable improvements in real-world adherence and long-term glycemic outcomes will require post-marketing data. Nonetheless, the availability of a once-weekly basal insulin option represents a structural shift in how insulin therapy can be delivered to the large population of adults with type 2 diabetes who need it. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Drug ApprovalPhase 3

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

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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	zdnrfzfelf(emqmlwxgmt): 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)	rrqkuuiere(zdkryjftfs) = kdcxighsvt oqyisqwrmd (ytxzvpgzms, 0.05) View more	-	04 Dec 2024
				Insulin Degludec (Insulin Degludec)	rrqkuuiere(zdkryjftfs) = ziygwtdhop oqyisqwrmd (ytxzvpgzms, 0.05) View more
NCT05243628 (ABC, CTgov)	Phase 4	Diabetes Mellitus, Type 1	33	insulin degludec+insulin human (Afrezza + Insulin Degludec)	rbpdxmacqo(toopzqgocg) = pxkmaagntk apfoodafoi (xkyvlwxdrz, 0.58) View more	-	18 Oct 2024
				Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) (AID Control)	rbpdxmacqo(toopzqgocg) = opbylrvldf apfoodafoi (xkyvlwxdrz, 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)	hchtpaiebv(zpbnhianyg) = kbhysauoru sspndrgtyh (hpywlxktve, nvsyvyuxem - ymhflxgdhe) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	hchtpaiebv(zpbnhianyg) = foybcgmxtz sspndrgtyh (hpywlxktve, lfyxkjgqko - wpjbqrbuga) View more
ADA2024 Manual	Not Applicable	Diabetes Mellitus, Type 2	159	fixed-ratio insulin degludec/liraglutideinsulin degludec/liraglutide (Intervention regimen)	gvqqgglnxc(dtznrlwpql) = hysnbmspga uusmifkgfu (zafhvbrmqn, 0.4) View more	Positive	21 Jun 2024
				Standard care	gvqqgglnxc(dtznrlwpql) = bsvcnjwetk uusmifkgfu (zafhvbrmqn, 0.6) View more
NCT05434559 (Pubmed \| Diabetes Technol Ther) Manual	Not Applicable	Diabetes Mellitus, Type 1	486	Insulin degludec	wabapckcxl(dhflfhdbum) = mhjioymqoh qfjtzacumt (cmsvovmtal ) View more	Positive	21 Mar 2024
				Other long-acting insulins	wabapckcxl(dhflfhdbum) = feoczubtsm qfjtzacumt (cmsvovmtal ) View more
NCT04450394 \| NCT03736785 \| NCT04450407 (phase 2, EASD2023)	Phase 2	-	912	Once-weekly insulin efsitora alfa	azvfzekbbc(xbzymzhtto) = eydgafmbob ytupikpbdh (lqklqeodav ) View more	Positive	03 Oct 2023
				Once daily degludec	azvfzekbbc(xbzymzhtto) = cjttcoxsph ytupikpbdh (lqklqeodav ) View more
NCT03882970 (SURPASS-3 MRI, EASD2023)	Phase 3	Diabetes Mellitus, Type 2 BMI \| fatty liver index \| triglycerides ... View more	-	Tirzepatide 5 mg	wwocfofqrk(amckrlylkk) = mgcakepteb gvqvsxyjdl (kjuvdcncex, 0.74)	Positive	03 Oct 2023
				Tirzepatide 10 mg	wwocfofqrk(amckrlylkk) = dyclhdixfv gvqvsxyjdl (kjuvdcncex, 0.74)
NCT04795531 (ONWARDS 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 2	588	Insulin icodec	kaemgkiahw(scxdhbimiy): 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	dbuxkkydzk(vrssprijyh) = puohzoxrmx sravrztvaj (egxlogjomb ) View more	Negative	03 Oct 2023
				Insulin degludec	dbuxkkydzk(vrssprijyh) = mvqueugvtf sravrztvaj (egxlogjomb ) View more

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Identify the latest clinical trials across global registries.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis