Fiasp (fast-acting insulin aspart) / Novo Nordisk - LARVOL DELTA

MiniMed 780G System Use with Fast-Acting Insulin Aspart by Adults with T1D (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Metabolic Disorders

Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Faster-Acting Insulin Aspart around Continuous Moderate Intensity Exercise in Adults with Type 1 Diabetes—A Randomised Controlled Trial (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • PK/PD data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

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

Faster-acting insulin aspart versus insulin aspart for adults with type 1 diabetes treated with non-automated insulin pump and continuous glucose monitoring-A double-blind randomized controlled crossover trial. (PubMed, Diabetes Obes Metab) - "Faster aspart improved baseline-adjusted TIR, TAR, CV and HbA1c after 16 weeks with frequent insulin pump adjustments but had a higher incidence of injection site reactions."

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

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

SENSOR-DERIVED GLYCEMIC METRICS IN WOMEN WITH TYPE 1 DIABETES USING INSULIN DEGLUDEC VS. OTHER BASAL INSULIN ANALOGS DURING PREGNANCY (ATTD 2025) - "The use of faster-acting insulin aspart and insulin aspart was equally distributed in the two groups. Severe hypoglycemia occurred in 1 (2%) vs. 5 (17%) (p=0.01). Birthweight standard deviation score was 1.5 ±1.2 vs. 0.8± 1.1 (p=0.01).Conclusions In this post-hoc analysis pregnant women with type 1 diabetes using insulin degludec achieved lower night-time TIRp, experienced less severe hypoglycemia and delivered infants who had less appropriate size compared to women using other basal insulin analogs."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

FAST-ACTING INSULIN ASPART INCREASES MAINLY THE TIME IN TIGHT RANGE AMONG T1DM INDIVIDUALS USING AN AUTOMATIC INSULIN PUMP (ATTD 2025) - "TITR's value increased from 41.6% to 47.5% (p<0.01).Conclusions Both TIR and TITR improved by 6-6%. The improvement in CGM data was mainly due to an increase in TITR, i.e., an increase in the time spent in normoglycemia."

Clinical • Type 1 Diabetes Mellitus

FAST-ACTING INSULIN ASPART IN ADULTS USING AN ADVANCED HYBRID CLOSED LOOP SYSTEM (ATTD 2025) - "While FA is associated with similar overall glycemic control to IAsp in AHCL, its use corresponds to more TIR70-180 after a meal challenge."

Clinical • Metastases • Hypoglycemia

USE OF ADVANCED HYBRID CLOSED LOOP SYSTEM (AHCLS) IN A PATIENT WITH MEN1 SYNDROME AND PANCREATOGENIC DIABETES: A CASE REPORT (ATTD 2025) - "He was educated in counting carbohydrates for meal coverage and an AHCLS Minimed 780G was placed with faster aspart insulin...Gradual amelioration is still being observed resulting also in better quality of life: TIR:90%, TAR:10%, TBR:0%, GMI:6,5% CV:22.9%, HbA1c: 6,8%Conclusions This case demonstrates that AHCLS can be beneficial in patients with PD enabling optimal glucose levels without high degree of hypoglycemia. Further studies should be conducted in order to determine the effectiveness of AHCLS in this rare group of patients."

Case report • Clinical • Metastases • Diabetes • Endocrine Cancer • Hypoglycemia • Metabolic Disorders • Oncology • Solid Tumor

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

FULLY CLOSED-LOOP IMPROVES GLYCAEMIC CONTROL COMPARED TO PUMP WITH CGM IN ADOLESCENTS WITH TYPE 1 DIABETES AND HBA1C ABOVE TARGET: A TWO-CENTRE, RANDOMISED CROSSOVER STUDY (ATTD 2025) - "Participants underwent two 8-week periods of unrestricted living comparing FCL (CamAPS HX) with faster-acting insulin aspart (Fiasp) with standard insulin pump therapy with CGM in random order...No severe hypoglycaemia or DKA events occurred. Conclusions Fully closed-loop insulin delivery with CamAPS HX improved glucose control compared with insulin pump therapy with CGM in adolescents with T1D and HbA1c above target."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Fully closed-loop - Insulin only approaches (ATTD 2025) - "Investigations performed with ultra-rapid insulin analogs (faster-aspart and ultra-rapid lispro) have shown so far variable and limited improvements of glucose control and patient satisfaction, depending of the AID system, participant age and tested ultra-rapid analog...A revision of control algorithms adapted to this new ecosystem is also needed. These exploratory pathways seem likely to allow ultimately fully closed-loop using insulin-only approaches."

Diabetes • Metabolic Disorders

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

New Insulin On Board Estimation for Artificial Pancreas Systems. (PubMed, Annu Int Conf IEEE Eng Med Biol Soc) - "This work presents a proposed method for calculating IOB based on mathematical modeling of Fiasp insulin, which is integrated into the control algorithm of the OpenAPS platform. The proposal is evaluated using a closed-loop system with a type 1 diabetic patient and real data from the Uva/Padova simulator. Simulation results show that the IOB calculation strategy reduces the average glucose level and increases the time spent in the desired control range."

Journal • Diabetes • Metabolic Disorders • Type 1 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

A comparison of ultra-rapid and rapid insulin in automated insulin delivery for type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Diabetes Obes Metab) - "AID-URAI slightly improves the percentage of TIR and has a good safety profile without increasing the risk of diabetic ketoacidosis and severe hypoglycemia."

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

Postprandial time in tight range with faster insulin aspart compared with standard insulin aspart in youth with type 1 diabetes using automated insulin delivery. (PubMed, Diabetes Obes Metab) - "Faster insulin formulation with AID improved postprandial glycaemic outcomes and could be a useful therapeutical option in youth with type 1 diabetes that have challenges achieving glycaemic targets."

Journal • Diabetes • Metabolic Disorders • Type 1 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

Sensor-derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster acting insulin aspart or insulin aspart-A secondary analysis of the CopenFast trial. (PubMed, Diabet Med) - "Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity."

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

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the Cambridge Hybrid Closed-Loop System for Individuals With Type 1 Diabetes. (PubMed, J Diabetes Sci Technol) - "There were no safety issues when using Boost and Ease-off with ultra-rapid insulins. The use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

CONNECT 1: A Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affects the Blood Sugar Level in Patients With Type 1 Diabetes as Part of Local Clinical Practice (clinicaltrials.gov) - P=N/A | N=411 | Completed | Sponsor: Novo Nordisk A/S | Enrolling by invitation ➔ Completed | N=227 ➔ 411

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Sensor-derived glycaemic metrics in women with type 1 diabetes using insulin degludec vs other basal insulin analogs during pregnancy: a post hoc analysis of the CopenFast trial (EASD 2024) - P3 | "Faster-acting insulin aspart or insulin aspart was used by 55% and 45% of women using insulin degludec and by 52% and 48% of women using other basal insulin analogs, respectively (p=0.93). Women with type 1 diabetes using insulin degludec achieved similar 24 h glycemic metrics, less favorable glycemic metrics during nighttime and delivered larger infants compared to women using other basal insulin analogs who in contrast experienced more severe hypoglycemia."

Clinical • Retrospective data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Sensor-derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster-acting insulin aspart or insulin aspart: a secondary analysis of the CopenFast trial (EASD 2024) - P3 | "Women with type 1 diabetes randomized to faster aspart achieved TIRp >70% earlier in pregnancy, had higher TIRp from 22 to 33 weeks, no severe hypoglycemia, and delivered infants with a more appropriate size compared to women randomized to IAsp."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Nocturnal Glucose Profile According to Timing of Dinner Rapid Insulin and Basal and Rapid Insulin Type: An Insulclock® Connected Insulin Cap-Based Real-World Study. (PubMed, Biomedicines) - "The dinner rapid insulin timing, insulin type, and the use of correction injections affect the nocturnal glucose profile in T1D."

Journal • Real-world • Real-world evidence • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus