Awiqli (insulin icodec) / Novo Nordisk - LARVOL DELTA

Cost-Effectiveness of Once-Weekly Insulin Icodec versus Daily Basal Insulins in Chinese Adults with T2DM: A Treatment-Background Stratified Analysis. (PubMed, Clinicoecon Outcomes Res) - "Insulin icodec offers cost-saving potential versus degludec in insulin-naïve T2DM patients. For basal and basal-bolus-treated patients, the clinical use of icodec needs to be critically evaluated for cost burden, and it is recommended that it be used preferentially in patients who are sensitive to the frequency of injections."

HEOR • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Case of Insulin Edema Syndrome Improved by Weekly Insulin. (PubMed, JCEM Case Rep) - "Weekly insulin icodec was introduced, which was well-tolerated by the patient and improved her adherence to therapy and her insulin edema without significant weight gain. Insulin edema is a diagnosis of exclusion, and clinicians should be aware of this clinical entity. The use of third-generation long-acting insulin analog may be helpful in some patients with this syndrome."

Journal • Diabetes • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Is once-weekly insulin a viable alternative for type 2 diabetes? A meta-analysis of randomized controlled trials. (PubMed, Diabetol Int) - "Once-weekly novel insulin preparations such as Icodec and basal insulin Fc (BIF)/insulin Efsitora Alfa have raised hope among clinicians and patients when they were developed and evaluated in a series of clinical trials...No significant differences were observed between once-weekly and once-daily insulin for other safety outcomes. Once-weekly insulin regimen was superior in reducing HbA1c level while maintaining a similar safety profile to the once-daily insulin regimen, thus suggesting that such regimen may potentially be an alternative to the currently established once-daily basal insulin regimen."

Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of once-weekly basal insulin therapy in people with type 1 diabetes: A systematic review and meta-analysis. (PubMed, Diabetes Obes Metab) - "This meta-analysis is the first to evaluate the efficacy and safety of once-weekly basal insulin therapy exclusively in adults with type 1 diabetes and including all published RCTs. The analysis demonstrated a similar glucose-lowering effect compared to once-daily basal insulin but revealed an increased occurrence of severe hypoglycaemia."

Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. (PubMed, Diabetes Ther) - P1 | "In Chinese individuals with T2D, icodec pharmacokinetics and semaglutide total exposure are unaffected when combining icodec and semaglutide in IcoSema. However, maximum semaglutide concentration is higher and occurs earlier with IcoSema. This information may help to ensure suitable dose recommendations for IcoSema."

Clinical • Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Once-Weekly Insulin Icodec in Indian Participants with Diabetes: Results from ONWARDS 1, 4, and 6 Studies. (PubMed, Diabetes Ther) - P3 | "Icodec demonstrated comparable efficacy and safety to once-daily basal insulins in Indian participants with T1D and T2D. These findings support icodec as a viable option for insulin initiation or intensification in Indian clinical practice."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

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. (Novo Nordisk Press Release) - "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."

FDA filing • Type 2 Diabetes Mellitus

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes (clinicaltrials.gov) - P4 | N=586 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Emerging perspectives on once-weekly insulins in type 1 and type 2 diabetes: a mini-review. (PubMed, Front Endocrinol (Lausanne)) - "The development of once-weekly basal insulin analogues, such as insulin icodec and efsitora alfa, represents a promising strategy to reduce injection burden and improve adherence in diabetes management...In type 1 diabetes, available data remain limited; however, the ONWARDS 6 and QWINT-5 trials demonstrated that once-weekly icodec and efsitora, respectively, achieved comparable reductions in HbA1c to once-daily insulin degludec, when used in combination with prandial insulin...Recent findings from the COMBINE program demonstrated that the fixed-ratio combination of icodec and semaglutide (IcoSema) produced superior HbA1c reductions compared to either agent alone, though not superior to a basal-bolus regimen with glargine and aspart insulin. However, several important questions remain to be addressed regarding once-weekly insulins, including their long-term efficacy on cardiovascular outcomes and overall long-term safety."

Clinical • Journal • Review • Cardiovascular • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Gan & Lee Pharmaceuticals.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of once-weekly basal insulin therapy in people with type 1 diabetes: a systematic review and meta-analysis (EASD 2025) - "We included randomized controlled trials (RCTs) comparing insulin icodec and efsitora against once-daily basal insulins in people with type 1 diabetes... This meta-analysis for the first time evaluated efficacy and safety of once-weekly basal insulins in the treatment of adults with type 1 diabetes, showing similar glucose-lowering effect with increased hypoglycemia occurrence and divergent findings on treatment satisfaction compared to once-daily compounds."

Retrospective data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in type 2 diabetes by diabetes duration: ONWARDS 1-5 (EASD 2025) - P3 | "Efficacy and hypoglycaemia outcomes for icodec vs OD comparators were overall similar across T2D duration subgroups."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Improved treatment satisfaction with once-weekly IcoSema vs daily basal-bolus therapy in adults with type 2 diabetes inadequately controlled on daily basal insulin: COMBINE 3 (EASD 2025) - P3 | "Supported by Medical writing support was provided by Oxford PharmaGenesis, funded by Novo Nordisk A/S Clinical Trial Registration Number: NCT05013229 (COMBINE 3) Background and aims: COMBINE 3 evaluated the efficacy and safety of IcoSema, a once-weekly combination of basal insulin icodec and the glucagon-like peptide-1 analogue semaglutide, vs daily basal-bolus therapy (BBT) in adults with type 2 diabetes (T2D). The statistically significant estimated improvement in the total treatment satisfaction score with once-weekly IcoSema vs daily BBT appeared to be driven by satisfaction with current treatment, convenience, flexibility, willingness to recommend treatment to others and satisfaction to continue trial treatment."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Gastrointestinal adverse events with once-weekly IcoSema: a post hoc analysis of COMBINE 1-3 (EASD 2025) - P3 | "Supported by Medical writing support was provided by Oxford PharmaGenesis, funded by Novo Nordisk A/S Clinical Trial Registration Number: NCT05352815 (COMBINE 1); NCT05259033 (COMBINE 2); NCT05013229 (COMBINE 3) Background and aims: The efficacy and safety of IcoSema, a once-weekly combination therapy of basal insulin icodec and semaglutide (a glucagon-like peptide-1 [GLP-1] analogue), were assessed in three 52-week, phase 3a trials (COMBINE 1-3). In participants receiving IcoSema, regardless of experiencing GIAEs, changes in HbA1c, body weight and actual weekly insulin dose over the treatment period, were broadly consistent with the overall findings reported for the COMBINE trials."

Adverse events • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Continuous glucose monitoring-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3 (EASD 2025) - P3 | "Supported by Study funded by Novo Nordisk A/S Clinical Trial Registration Number: COMBINE 1 (NCT05352815); COMBINE 3 (NCT05013229) Background and aims: This post hoc analysis investigated whether IcoSema, a once-weekly (OW) combination therapy of basal insulin icodec and the GLP-1 analogue semaglutide currently in development, offers a postprandial glucose (PPG) control benefit vs other insulin-based regimens.Materials and COMBINE 1 and 3, two 52-week, phase 3a trials, investigated IcoSema vs OW basal insulin (icodec; COMBINE 1) or basal-bolus therapy (glargine U100 + aspart; COMBINE 3) in adults with type 2 diabetes (T2D) who were inadequately controlled on daily basal insulin. Based on post hoc modelling using CGM data, IcoSema showed statistically significantly better PPG control vs OW basal insulin and similar PPG control vs basal-bolus therapy."

Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Continuous glucose monitoring-based outcomes in adults with type 2 diabetes receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3 (EASD 2025) - P3 | "Supported by Medical writing support was provided by Oxford PharmaGenesis, funded by Novo Nordisk A/S Clinical Trial Registration Number: COMBINE 1 (NCT05352815); COMBINE 3 (NCT05013229) Background and aims: IcoSema is a once-weekly combination therapy of basal insulin icodec (icodec) and the glucagon-like peptide-1 analogue semaglutide. Between weeks 48-52, TiTR was significantly higher with IcoSema vs icodec and similar vs BBT. More participants on IcoSema vs comparators achieved the CGM composite outcome, CV% was <36% and median overall hypoglycaemia duration was similar between arms."

Clinical • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and hypoglycaemia outcomes of once-weekly IcoSema in type 2 diabetes according to pre-trial sodium-glucose cotransporter-2 inhibitor use: a post hoc analysis of COMBINE 1-3 (EASD 2025) - P3 | "Clinical Trial Registration Number: COMBINE 1 (NCT05352815); COMBINE 2 (NCT05259033); COMBINE 3 (NCT05013229) Background and aims: IcoSema (a once-weekly combination therapy of insulin icodec [icodec] and semaglutide, a glucagon-like peptide-1 analogue) has been investigated in three 52-week, phase 3a trials (COMBINE 1-3). Overall, efficacy and hypoglycaemia outcomes were generally consistent with IcoSema vs comparators among adults with T2D, irrespective of pre-trial SGLT2i use."

Clinical • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in type 2 diabetes by baseline HbA1c: ONWARDS 1-5 (EASD 2025) - P3 | "Efficacy and hypoglycaemia outcomes for icodec vs OD comparators were overall similar across baseline HbA1c subgroups."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar (clinicaltrials.gov) - P=N/A | N=245 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

ONWARDS 11: A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes (clinicaltrials.gov) - P3 | N=877 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Comparison Study of Insulin GZR4 With Insulin Degludec (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Gan and Lee Pharmaceuticals, USA

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-weekly insulin icodec vs. daily insulin glargine in type 2 diabetes: a meta-analysis with longitudinal insights. (PubMed, Ann Med Surg (Lond)) - "Insulin icodec provides a safe and effective alternative to once-daily insulin glargine for T2DM management, offering similar glycemic control with a once-weekly dosing regimen. The reduced injection burden may enhance adherence and treatment satisfaction, potentially improving long-term disease outcomes."

Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Awiqli® - erstes Wocheninsulin. (PubMed, MMW Fortschr Med) - No abstract available

Journal

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada. (PubMed, J Med Econ) - "Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).ResultsIn all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.LimitationsLimitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.ConclusionsInsulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada."

HEOR • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) (clinicaltrials.gov) - P3 | N=485 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus