NovoLog (insulin aspart) / Novo Nordisk - LARVOL DELTA

Comparing Medicare Maximum Fair Prices with Other Drug Prices in Other Countries (ISPOR 2025) - "Approximate monthly costs were calculated and compared between the countries. The comparison showed that the costs of the 10 drugs included in the Part D negotiations (Januvia, Fiasp/NovoLog/NovoRapid insulin products, Farxiga/Forxiga, Enbrel, Jardiance, Xarelto, Eliquis, Entresto, Stelara, and Imbruvica) were still lower in other countries even after price negotiations. Despite substantial discounts provided by Medicare price negotiations, US maximum fair prices remain generally higher than prices applied in other countries with high healthcare spending per capita. A limitation of the analysis is the approximation of monthly drug costs without utilization data."

Medicare • Reimbursement • US reimbursement

RANDOMISED OPEN-LABEL CLINICAL TRIAL EXAMINING THE SAFETY AND EFFICACY OF THE ANDROID ARTIFICIAL PANCREAS SYSTEM WITH ADVANCED BOLUS-FREE FEATURES: THE CLOSE IT TRIAL (ATTD 2025) - "Full results will be available for presentation at ATTD 2025."

Clinical • Metastases • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

INFLUENCE OF DIETS DIFFERING IN MACRONUTRIENT COMPOSITION ON ENERGY METABOLISM DURING SUSTAINED, SUBMAXIMAL EXERCISE IN ADULTS WITH TYPE 1 DIABETES (ATTD 2025) - "This study profiled the metabolic responses to fasted submaximal cycling in adults with T1D following 7-days of adherence to diets differing in macronutrient composition.Methods In a randomised crossover design, 12 adults with T1D (n=4 female, age: 46±15 years, HbA1c: 55.9±7.8 mmol/mol) managed by non-automated insulin pump (n=9 Novorapid, n=3 Fiasp) consumed three diets over 7-days: HCLFLP (high carbohydrate (48%), low fat (33%), low protein (19%)), LCHFLP (low carbohydrate (19%), high fat (62%), low protein (19%)) and LCLFHP (low carbohydrate (19%), low fat (57%), high protein (24%)). Carbohydrate oxidation was greater in HCLFLP compared to LCHFLP (p=0.030), with concomitantly lower lipid oxidation (Table 1, p=0.030). Conclusions A 7-day low carbohydrate diet influenced fasted exercise metabolism with lower carbohydrate oxidation and circulating fatty acids despite similar glycaemic patterns in adults with T1D."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

CLOSE IT - Results from a randomized controlled fully closed loop trial (ATTD 2025) - "Twenty FCL arm participants will participate in a 4-week extension phase comparing NovoRapid® (insulin aspart) to Fiasp® (insulin aspart and niacinamide). Baseline data include median age 36 years (interquartile range, IQR 26-46), 48% female gender, median diabetes duration 19 years (IQR 11-30), 46% existing insulin pump users, median HbA1c 57mmol/mol (IQR 50-63). Conclusions Full results will be available for presentation at ATTD 2025."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients (clinicaltrials.gov) - P2/3 | N=65 | Terminated | Sponsor: University of Minnesota | Completed ➔ Terminated

Trial termination • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Impact of Meal Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients. (PubMed, Diabetes Technol Ther) - "Research Design and We conducted a post hoc analysis from the In-Fi study: a randomized controlled trial comparing Fiasp versus insulin aspart (Novolog) in inpatients with type 2 diabetes. Delayed mealtime insulin administration and bedtime snacking without insulin administration are significant causes of postprandial and overnight hyperglycemia in hospitalized inpatients. Adjustments in mealtime insulin protocols, attention to food intake, and the potential inpatient adoption of technology, such as CGM and automated insulin delivery systems, are needed to address this shortcoming in inpatient diabetes care."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

MIRE: Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes (clinicaltrials.gov) - P4 | N=38 | Terminated | Sponsor: University Hospital, Strasbourg, France | Trial completion date: Aug 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2025 ➔ Jan 2025; Difficulties of inclusion in this rare pathology

Trial completion date • Trial primary completion date • Trial termination • Cystic Fibrosis • Diabetes • Genetic Disorders • Immunology • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases

Oral Anti Diabetic Agents in the Hospital (clinicaltrials.gov) - P4 | N=260 | Recruiting | Sponsor: Emory University | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Nov 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders

Efficacy, safety, and immunogenicity of recombinant insulin aspart (BioGenomics Limited) and NovoRapid® (Novo Nordisk) in adults with type 2 diabetes mellitus: a randomized, open-label, multicenter, phase-3 study. (PubMed, Res Pharm Sci) - "Eighteen (11.3%) patients in the BGL-ASP group and 23 (14.4%) in the NovoRapid®group reported adverse events. BGL-ASP and NovoRapid®were comparable and equally effective in lowering HbA1c, FPG, and PPG levels, with similar immunogenicity and safety profiles."

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

Comparing Postprandial Glycemic Control using Fiasp vs. Insulin Aspart in Hospitalized Patients with Type 2 Diabetes. (PubMed, Endocr Pract) - "Fiasp provides non-inferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia."

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

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Xentria, Inc. | Active, not recruiting ➔ Completed

Trial completion

"Double C" plan for blood glucose control and pregnancy outcome of gestational diabetes observe (ChiCTR) - P1 | N=120 | Recruiting | Sponsor: Jiangxi Maternal and Child Health Hospital; Jiangxi Maternal and Child Health Hospital

New P1 trial • Diabetes • Gestational Diabetes • Metabolic Disorders

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Xentria, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

TREATING DIABETIC KETOACIDOSIS IN A PATIENT ALLERGIC TO REGULAR INSULIN (CHEST 2024) - "Initial serology concerning forDKA but unable to start an insulin drip given documented anaphylactic reaction to Humulin-R...This was performed on the patient, and he was treated with NovoLog subcutaneous dosing every 2 hours for treatment of DKA.While no standardized protocol exists for insulin desensitization, various ultra-rush desensitization protocols advocate using Insulin preparations of decreasing concentrations (1:10, 1:100, 1:1000), given in small increments to patients (doses vary from 0.001 unit to 0.1 unit per dose)...This is done in a monitored setting with equipment to treat anaphylaxis, including epinephrine, diphenhydramine, intravenous fluid, and readily available steroids... Insulin is vital to the treatment of diabetes and its life-threatening complications, including DKA. Allergy to the insulin molecule is rare and poses challenges to treatment in the critical care unit. Using a less immunogenic formulation and/or a rapid desensitization protocol may..."

Clinical • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

Patients with type 2 diabetes who achieve reduced postprandial glucose levels during insulin intensive therapy may have a better recovery of β-cell function. (PubMed, Diabetes Res Clin Pract) - "Drug-naïve T2D patients with lower postprandial glucose concentration during CSII therapy exhibit better β-cell function recovery."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Xentria, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Randomized Controlled Trial of Three- and Seven-days Insulin Infusions Set (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Steno Diabetes Center Copenhagen

New trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid® (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Xentria, Inc.

New P1 trial

Comparison of HR011408 and NovoRapid® in Subjects With Diabetics (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders

Comparison of HR011408 and NovoRapid® in Subjects With Diabetics (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders

What will be the impact on minority groups in 2026 when Medicare Part D price cuts take effect? (AMCP 2024) - "All 3 groups have higher use than Medicare enrollees overall, for use of selected diabetes drugs, Farxiga (dapagliflozin), Januvia (sitagliptin), and Jardiance (empagliflozin). Black and Latino enrollees also index higher for use of Novolog/Fiasp (insu- lin aspart)...Latino people’s index high for use of Enbrel (etan- ercept)... Unlike the IRA’s $35 insulin cap, elimination of OOP costs on adult vaccines and expansion of the Low- Income Subsidy Program, Part D Price Negotiation will not lower OOP costs for enrollees including the ethnic groups highlighted by HHS. Ways to make selected drugs more affordable to disadvantaged populations should be considered."

Medicare • Reimbursement • US reimbursement • Diabetes • Metabolic Disorders

Enhanced recovery after surgery: Preoperative carbohydrate loading and insulin management in type 2 diabetes. (PubMed, Surg Open Sci) - "Patients enrolled in an ERAS® protocol with concomitant type 2 diabetes received rapid acting insulin (Novolog®[insulin aspart]) prior to 50 g CHO-L on the day of surgery...Our experience demonstrates that administering rapid acting insulin prior to CHO-L in patients with type 2 diabetes is feasible and targets the potentially negative influence CHO-L may impose on preoperative glycemia in this population. Important considerations of this approach are highlighted and an insulin dosing algorithm designed for non-specialty providers is suggested."

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

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial. (PubMed, J Diabetes Sci Technol) - "SAR341402 insulin aspart (SAR-Asp) is a rapid-acting insulin analog developed as an interchangeable biosimilar to the marketed insulin aspart reference product (NovoLog; NN-Asp)...This report assessed whether multiple switches between SAR-Asp and NN-Asp lead to equivalent safety and efficacy compared with continuous use of NN-Asp in adults with type 1 diabetes (T1D) treated with multiple daily injections, using once-daily insulin glargine U100 (Lantus) as the basal insulin...Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management."

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

Study protocol for a randomised open-label clinical trial examining the safety and efficacy of the Android Artificial Pancreas System (AAPS) with advanced bolus-free features in adults with type 1 diabetes: the 'CLOSE IT' (Closed Loop Open SourcE In Type 1 diabetes) trial. (PubMed, BMJ Open) - "Twenty FCL arm participants will participate in a 4-week extension phase comparing glycaemic and dietary outcomes using NovoRapid (insulin aspart) to Fiasp (insulin aspart and niacinamide). Study results will be disseminated by publications, conferences and patient advocacy groups. ACTRN12622001400752 and ACTRN12622001401741."

Journal • Metastases • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus