Awiqli (insulin icodec) / Novo Nordisk - LARVOL DELTA

Insulin Efsitora Demonstrates Similar Efficacy and Safety Profiles to Insulin Icodec in Insulin-Experienced Individuals With Type 2 Diabetes Mellitus: Matching-Adjusted Indirect Comparisons of QWINT-3 Versus ONWARDS 2, and QWINT-4 Versus ONWARDS 4. (PubMed, Diabetes Obes Metab) - "These indirect comparisons suggest that efsitora had lower event rates of hypoglycaemia and less weight gain compared to icodec in basal insulin-experienced participants. Efsitora was comparable to icodec for all other endpoints."

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

A case report of insulin edema associated with insulin icodec. (PubMed, Endocrinol Diabetes Metab Case Rep) - "Insulin edema is a rare complication that may occur after the initiation of insulin therapy. Although it usually resolves promptly after discontinuation of insulin, severe cases can lead to pulmonary edema, congestive heart failure, and acute renal failure. Insulin icodec is a recently marketed once-weekly, long-acting basal insulin, and its clinical use is increasing in Japan because it offers the convenience of once-weekly administration with an acceptable safety profile. In this report, we describe what is, to our knowledge, the first case of edema associated with insulin icodec. An 82-year-old man with glucocorticoid-induced diabetes mellitus in the setting of pre-existing impaired glucose metabolism was started on insulin icodec because of worsening glycemic control and developed bilateral leg edema a few days after the first injection. As he had no signs of heart failure, liver disease, or renal impairment, insulin icodec-induced edema was suspected, and insulin..."

Journal • Acute Kidney Injury • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Hepatology • Liver Failure • Metabolic Disorders • Renal Disease • Respiratory Diseases

A case report of young-onset type 2 diabetes patient with severe metabolic dysregulation carrying an LRP6 variant. (PubMed, Front Endocrinol (Lausanne)) - "Multidisciplinary treatment-incorporating acute-phase plasma exchange, ω-3 fatty acid ethyl ester 90, inclisiran, subcutaneous insulin aspart pump therapy, metformin, insulin icodec, finerenone, and Huangkui capsules-led to improvements in the patient's metabolic indicators. This case emphasizes that genetic variant screening should be considered in patients with unexplained severe metabolic disturbances, particularly those with early-onset disease. This case also provides a foundation for future functional studies and genetic confirmation."

Journal • Diabetes • Diabetic Nephropathy • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Nephrology • Pancreatitis • Renal Disease • Severe Hypertriglyceridemia • Type 2 Diabetes Mellitus

ICOSWITCH REAL: A Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec (clinicaltrials.gov) - P=N/A | N=214 | Enrolling by invitation | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Enrolling by invitation

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

Once-weekly insulin icodec (Awiqli) for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males (clinicaltrials.gov) - P1 | N=53 | Recruiting | Sponsor: The United Bio-Technology (Hengqin) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

ICOSWITCH REAL: Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec (clinicaltrials.gov) - P=N/A | N=216 | Enrolling by invitation | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Enrolling by invitation

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

Continuous glucose monitoring-based metrics in adults switching to once-weekly icodec without an initial one-time additional dose vs once-daily glargine U100: post hoc analysis of ONWARDS 10 (EASD 2026) - P3 | "Once-weekly insulin icodec, with a half-life of approx. 8 days, provides flexibility to switch from daily insulins with or without a one-time additional dose. Switching without a one-time additional dose is efficacious and can simplify treatment in adults with T2D without increasing TAR."

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

Efficacy and hypoglycaemia outcomes with once-weekly IcoSema vs glargine U100 in type 2 diabetes by baseline BMI: COMBINE 4 (EASD 2026) - P3 | "Supported by: Novo Nordisk A/S Clinical Trial Registration Number: NCT06269107 Background and aims: In COMBINE 4, IcoSema (a once-weekly combination of basal insulin icodec and the GLP-1 analogue semaglutide) showed superior glycaemic control and change in body weight, with lower rates of combined clinically significant or severe hypoglycaemia versus insulin glargine U100 in insulin-naive individuals with type 2 diabetes (T2D). In insulin-naïve individuals with T2D, efficacy and hypoglycaemic outcomes with IcoSema versus glargine U100 were overall consistent regardless of baseline BMI."

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

Efficacy and hypoglycaemia outcomes with once-weekly IcoSema vs glargine U100 in type 2 diabetes by baseline HbA1c: COMBINE 4 (EASD 2026) - P3 | "Supported by: Novo Nordisk A/S Clinical Trial Registration Number: NCT06269107 Background and aims: In COMBINE 4, IcoSema (a once-weekly combination of basal insulin icodec and the GLP-1 analogue semaglutide) showed superior glycaemic control and change in body weight, with lower rates of combined clinically significant or severe hypoglycaemia versus insulin glargine U100 in insulin-naive individuals with type 2 diabetes (T2D). In insulin-naïve individuals with T2D, efficacy and hypoglycaemic outcomes with IcoSema versus glargine U100 were overall consistent regardless of baseline HbA 1c ."

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

Real-world safety of weekly insulin icodec during fasting: implications for hypoglycaemia prevention and patient well-being (EASD 2026) - "Appropriately administered Ico indicated no hypoglycemia during a two-day fast. Upon three or more anticipated days of fasting, glucose administration (intravenously or orally) should be considered."

Clinical • Real-world • Real-world evidence • Hypoglycemia • Metabolic Disorders

Cardiometabolic outcomes of once-weekly IcoSema in adults with type 2 diabetes: systematic review and meta-analysis of the COMBINE trials. (PubMed, Cardiovasc Diabetol Endocrinol Rep) - "Once-weekly IcoSema delivers meaningful improvements in weight, blood pressure, and atherogenic lipids, all key modifiable drivers of ASCVD in adults with type 2 diabetes. These surrogate benefits, combined with reduced injection burden and low risk of hypoglycemia, suggest potential for enhanced ASCVD prevention and improved long-term adherence. Results should be interpreted as hypothesis-generating only because only two trials met the inclusion criteria. Dedicated cardiovascular outcome trials are essential to validate these surrogate-marker benefits and to confirm whether they translate into a reduction in cardiovascular events."

Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 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 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

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

Dual C20 Fatty Acid-Conjugated Insulin Analog LPJT-026: Enhanced HSA Binding, Prolonged PK/PD Profiles, and Reduced Hypoglycemia Risk for Biweekly Diabetes Therapy. (PubMed, Pharm Res) - "Dual fatty acid conjugation enables LPJT-026 to form a stable HSA-binding reservoir, achieving biweekly dosing potential, superior glycemic control, and improved safety. LPJT-026 represents a promising next-generation therapy for insulin-dependent diabetes."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • IR

Efficacy and safety of insulin icodec compared with insulin efsitora in patients with type 2 diabetes: a systematic review and network meta-analysis. (PubMed, Front Endocrinol (Lausanne)) - "Regarding safety outcomes, insulin degludec had a lower incidence of both level 1 and level 2 or 3 hypoglycemia than the other three insulins. Direct head to head RCTs are warranted to confirm these findings. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251177019."

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

Pharmacokinetics, Clinical Efficacy, and Safety of Once-Weekly Insulin Icodec: A Structured Narrative Review (2022-2026). (PubMed, Cureus) - "However, in patients with type 1 diabetes (T1D) (ONWARDS 6), while glycemic efficacy was non-inferior, icodec was associated with a statistically significant increase in the risk of severe or clinically significant hypoglycemia compared to insulin degludec. Insulin icodec may represent an important advancement in the management of T2D, offering improved glycemic control with a substantially reduced injection burden. While its use in T1D requires cautious consideration due to hypoglycemia risks, icodec has the potential to become a preferred standard of care for insulin-requiring T2D globally."

Journal • PK/PD data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Once-weekly IcoSema versus once-daily insulin glargine U100 in type 2 diabetes management (COMBINE 4): an open-label, multicentre, treat-to-target, randomised, phase 3b trial. (PubMed, Lancet Diabetes Endocrinol) - P3 | "Once-weekly IcoSema demonstrated superior HbA1c reduction and bodyweight change, with lower rates of clinically significant or severe hypoglycaemia, versus glargine U100, suggesting that IcoSema might be an effective once-weekly treatment option for insulin-naive individuals with type 2 diabetes inadequately controlled on oral glucose-lowering medications."

Journal • P3 data • Cognitive Disorders • Diabetes • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Severe Hypoglycemia • 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 | Trial completion date: Aug 2028 ➔ Mar 2028 | Trial primary completion date: Aug 2026 ➔ Mar 2028

Real-world evidence • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Hypoglycaemia Outcomes With Once-Weekly IcoSema Versus Comparators in Individuals With Type 2 Diabetes by Kidney and Liver Function: A Post Hoc Analysis of the COMBINE 1-3 Trials. (PubMed, Diabetes Obes Metab) - P3 | "Efficacy and hypoglycaemia outcomes with IcoSema versus comparators were generally consistent among adults with T2D with mild to moderate kidney impairment or impaired liver function."

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

Insulin Icodec Initiation Strategies and Day-4 Supplemental Dosing in Type 2 Diabetes (clinicaltrials.gov) - P4 | N=462 | Not yet recruiting | Sponsor: Xi'an International Medical Center Hospital

New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Projecting the Long-Term Cost-Effectiveness of Once-Weekly Insulin Icodec Versus Once-Daily Basal Insulin Analogs in Italy Using the Prime T2D Model. (PubMed, Diabetes Obes Metab) - "Icodec was projected to be cost-effective versus once-daily insulins for insulin-naïve people with T2D in Italy."

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

Clinical Trials of IBI3035 in Healthy Subjects (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Exercise or Fasting in Individuals With Type 2 Diabetes Receiving Once-Weekly Basal Insulin Icodec. (PubMed, Diabetes Obes Metab) - P1 | "The current results reinforce the safety profile of once-weekly basal insulin icodec and provide guidance on glycaemic management during exercise or fasting in people with T2D treated with icodec."

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

Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8). (PubMed, Diabetes Obes Metab) - P3 | "Intensification of icodec with semaglutide was feasible, with low rates of clinically significant or severe hypoglycaemia."

Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

ICOSWITCH REAL: Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec (clinicaltrials.gov) - P=N/A | N=216 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New trial • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus