Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

Start Date01 Sep 2024

Sponsor / Collaborator

University of Iowa

NCT06532461 / RecruitingNot ApplicableIIT

A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

Start Date20 Jul 2024

Sponsor / Collaborator

Steno Diabetes Center A/S

NCT06558708 / RecruitingPhase 2

A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin

This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.

Start Date28 Jun 2024

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Insulin aspart

100 Translational Medicine associated with Insulin aspart

100 Patents (Medical) associated with Insulin aspart

1,376

Literatures (Medical) associated with Insulin aspart

01 Nov 2024·DIABETOLOGIA

Assessing the influence of insulin type (ultra-rapid vs rapid insulin) and exercise timing on postprandial exercise-induced hypoglycaemia risk in individuals with type 1 diabetes: a randomised controlled trial

Article

Author: Molveau, Joséphine ; Tagougui, Sémah ; St-Amand, Roxane ; Rabasa-Lhoret, Rémi ; Myette-Côté, Étienne ; Heyman, Elsa ; Taleb, Nadine ; Suppère, Corinne ; Bourdeau, Valérie

AIMS/HYPOTHESIS:

The relationship between pre-meal insulin type, exercise timing and the risk of postprandial exercise-induced hypoglycaemia in people living with type 1 diabetes is unknown. We aimed to evaluate the effects of exercise timing (60 vs 120 min post meal) and different insulin types (aspart vs ultra-rapid aspart) on hypoglycaemic risk.

METHODS:

This was a four-way crossover randomised trial including 40 individuals with type 1 diabetes using multiple daily injections (mean HbA_1c 56 mmol/mol [7.4%]). Participants, who were recruited from the Montreal Clinical Research Institute, undertook 60 min cycling sessions (60% of __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ V ˙ O 2 peak ) after breakfast (60 min [EX60min] or 120 min [EX120min] post meal) with 50% of their usual insulin dose (aspart or ultra-rapid aspart). Eligibility criteria included age ≥18 years old, clinical diagnosis of type 1 diabetes for at least 1 year and HbA_1c ≤80 mmol/mol (9.5%). Participants were allocated using sequentially numbered, opaque sealed envelopes. Participants were masked to their group assignment, and each participant was allocated a unique identification number to ensure anonymisation. The primary outcome was change in blood glucose levels between exercise onset and nadir.

RESULTS:

Prior to exercise onset, time spent in hyperglycaemia was lower for EX60min vs EX120min (time >10.0 mmol/l: 56.6% [1.2-100%] vs 78.0% [52.7-97.9%]; p<0.001). The glucose reduction between exercise onset and nadir was less pronounced with EX60min vs EX120min (-3.8±2.7 vs -4.7±2.5 mmol/l; p<0.001). A similar number of hypoglycaemic events occurred during both exercise timings. Blood glucose between exercise onset and nadir decreased less with ultra-rapid aspart compared with aspart (-4.1±2.3 vs -4.4±2.8 mmol/l; p=0.037). While a similar number of hypoglycaemic events during exercise were observed, less post-exercise hypoglycaemia occurred with ultra-rapid aspart (n=0, 0%, vs n=15, 38%; p=0.003). No interactions between insulin types and exercise timings were found.

CONCLUSIONS/INTERPRETATION:

EX60min blunted the pre-exercise glucose increase following breakfast and was associated with a smaller glucose reduction during exercise. Ultra-rapid aspart led to a smaller blood glucose reduction during exercise and might be associated with diminished post-exercise hypoglycaemia.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT03659799 FUNDING: This study was funded by Novo Nordisk Canada.

01 Nov 2024·DIABETES OBESITY & METABOLISM

The efficacy and safety of insulin glargine 100 U/mL + lixisenatide versus insulin degludec + insulin aspart in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli‐D randomized controlled trial

Letter

Author: Mu, Yiming

18 Oct 2024·Journal of diabetes science and technology

Impact of Ultra-Rapid Insulin on Boost and Ease-Off in the Cambridge Hybrid Closed-Loop System for Individuals With Type 1 Diabetes.

Article

Author: Allen, Janet M ; Mader, Julia K ; Thabit, Hood ; Ware, Julia ; Evans, Mark L ; Hartnell, Sara ; Royston, Chloë ; Lakshman, Rama ; Boughton, Charlotte ; Bally, Lia ; Hovorka, Roman ; Wilinska, Malgorzata E ; Nwokolo, Munachiso ; Leelarathna, Lalantha

OBJECTIVE:

The objective was to evaluate the safety and efficacy of ultra-rapid-acting insulin with the Boost and Ease-off features of the Cambridge hybrid closed-loop system.

METHODS:

A secondary analysis of Boost and Ease-off from two double-blind, randomized, crossover hybrid closed-loop studies comparing (1) Fiasp to insulin aspart (n = 25), and (2) Lyumjev to insulin lispro (n = 26) was carried out. Mean glucose on initialization of Boost and Ease-off, change in glucose 60 and 120 minutes after initialization, duration and frequency of use, mean glucose, and time in, above, and below target glucose range were calculated for periods of Boost use, Ease-off use, or neither.

RESULTS:

Participants used Boost for longer with Fiasp than insulin aspart (median [interquartile range, IQR] = 75 [53-125] minutes vs 60 [49-75] minutes; P = .01). Mean glucose on Boost initialization with Fiasp was 238 ± 62 mg/dL compared with 218 ± 45 mg/dL with insulin aspart (P = .08). Fiasp use resulted in a greater glucose reduction 120 minutes after Boost initialization [-59 ± 34 mg/dL vs -43 ± 31 mg/dL; P = .02]. There were no statistically significant differences in sensor glucose endpoints during Boost or Ease-off periods between Fiasp and aspart. There were no statistically significant differences during Boost or Ease-off periods when comparing Lyumjev with insulin lispro. There were no safety issues when using Boost and Ease-off with ultra-rapid insulins.

CONCLUSIONS:

The use of Fiasp and Lyumjev during Boost or Ease-off resulted in comparable safety and efficacy to using insulin aspart and lispro.

News (Medical) associated with Insulin aspart

15 Oct 2024

·pipelinereview.com

Gan & Lee Pharmaceuticals' Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies

BEIJING, China I October 15, 2024 I Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that three of its independently developed drugs — the bi-weekly GLP-1 receptor agonist GZR18 injection, the once-weekly basal insulin analog GZR4 injection, and the premixed dual insulin analog GZR101 injection — successfully achieved positive results in three Phase 2 clinical trials conducted in adult patients with Type 2 diabetes (T2D) in China. In these studies, Gan & Lee’s three innovative drugs demonstrated superior or comparable efficacy in lowering glycated hemoglobin (HbA1c) compared to the respective positive comparator drugs separately. Gan & Lee Pharmaceuticals’ Diabetes Product Portfolio Diagram Statement: 1. GZR18, GZR4, and GZR101 are investigational drugs that have not yet been approved in China. 2. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. GZR18 Injection: a Phase 2 Study evaluate the Efficacy and Safety of GZR18 Injective vs. Semaglutide (Ozempic ® ) in Chinese Patients with Type 2 Diabetes The Phase 2b clinical trial (CTR20232069) is a multicenter, randomized, open-label study comparing the efficacy and safety of GZR18 injection versus semaglutide (Ozempic ® ) in Chinese adult T2D patients with poor glycemic control on lifestyle interventions and/or unregulated use of anti-diabetic drugs, and on oral anti-diabetic treatment for at least three months. A total of 264 subjects were recruited across 25 clinical centers in China. Patients were randomized to receive bi-weekly GZR18 injections (12 mg, 18 mg, or 24 mg) or once-weekly 24 mg GZR18 injections, or 1 mg semaglutide for 24 weeks, including the dose-escalation period. The primary efficacy endpoint was the change in HbA1c from baseline after 24 weeks of continuous treatment. The subjects had a mean diabetes history of 11-18 years, and baseline HbA1c ranged from 8.28% to 8.56%. After 24 weeks of treatment, the mean HbA1c reduction from baseline in the GZR18 groups was as follows: 1.87% (12 mg, bi-weekly), 2.28% (18 mg, bi-weekly), 1.94% (24 mg, bi-weekly), and 2.32% (24 mg, once-weekly), all higher than the semaglutide group (1.60% reduction)*. Additionally, in treatment-naïve patients with poor glycemic control on lifestyle interventions, the HbA1c reduction in the bi-weekly GZR18 injection group reached 2.98%, compared to 2.04% in the semaglutide group, with a significant HbA1c reduction (p < 0.05)*. After 24 weeks of treatment, patients in the bi-weekly GZR18 group experienced a maximum weight loss of 5.42 kg, compared to 3.25 kg in the semaglutide group*. GZR18 also greatly improved fasting glucose, blood pressure, and lipid levels, etc, providing comprehensive benefits for diabetic patients. GZR18 was generally well-tolerated, with safety and tolerability consistent with known GLP-1 receptor agonists. The most common adverse events were gastrointestinal-related, and no severe hypoglycemic events were observed. GZR4 Injection: a Phase 2 Study Comparing the Efficacy and Safety of GZR4 injection vs. insulin degludec (Tresiba ® ) in Chinese Patients with Type 2 Diabetes The Phase 2 trial (CTR20232431) was a multicenter, randomized, open-label, parallel-group study evaluating the efficacy, tolerability and safety of once-weekly GZR4 injections versus once-daily insulin degludec (Tresiba ® ) in 83 T2D patients with poor glycemic control on oral antidiabetic drugs (Part A) and 96 T2D patients with poor glycemic control on a combination of oral antidiabetic drugs and basal insulins (Part B). In part A, the mean HbA1c reduction of once-weekly GZR4 injection was 1.50%, comparable to insulin degludec’s reduction of 1.48%. In part B, GZR4 injection demonstrated a superior HbA1c reduction of 1.26%, compared to -0.87% for insulin degludec (treatment difference: -0.38%, p < 0.01)*. In addition, improvements in time-in-range (TIR) were comparable between GZR4 and insulin degludec. In this study, GZR4 injection showed good safety and tolerability, with no severe hypoglycemic events observed. GZR101 Injection: a Phase 2 Study Comparing the Efficacy and Safety of GZR101 injection vs. insulin degludec/insulin aspart (Ryzodeg ® ) in Chinese Patients with Type 2 Diabetes The Phase 2 clinical trial (CTR20232431) is a multicenter, randomized, open-label, parallel-controlled, treat-to-target Phase 2 study. Part A of the study aimed to compare the efficacy, safety, and tolerability of GZR101 injection administered once-daily versus insulin degludec/insulin aspart (Ryzodeg ® ) administered once-daily over 16 weeks in 62 patients with uncontrolled T2D on oral anti-diabetic drugs. In Part B, the study compared the efficacy, safety, and tolerability of GZR101 injection combined with insulin aspart versus insulin degludec/insulin aspart (Ryzodeg ® ) administered twice-daily over 16 weeks in 91 patients with uncontrolled T2D on basal/premixed insulin. In Part A, the HbA1c levels in the once-daily GZR101 injection group decreased by 1.56%, superior to the -1.31% reduction in the once-daily insulin degludec/insulin aspart group (treatment difference: -0.24%). In Part B, GZR101 injection combined with insulin aspart achieved HbA1c reductions of -1.64% (once-daily insulin aspart) and -1.68% (twice-daily insulin aspart), both higher than the -1.59% reduction in the twice-daily insulin degludec/insulin aspart group (treatment differences of -0.06% and -0.09%, respectively)*. Moreover, GZR101 injection demonstrated comparable efficacy to insulin degludec/insulin aspart in controlling fasting and postprandial blood glucose, as well as improving time-in-range (TIR). In this trial, GZR101 injection showed good safety and tolerability. The estimated incidence of hypoglycemic events in both groups did not show statistically significant differences during the study. *The trial results are presented as least squares means (LS mean). Note: severe hypoglycemia is defined as Grade 3 hypoglycemia (serious events without specific plasma glucose boundaries, with conscious and/or somatic changes, hypoglycemia requiring help from others). Dr. Zhong-ru Gan, Chairman of Gan & Lee Pharmaceuticals, stated: “The positive results achieved by GZR18, GZR4, and GZR101 in Phase 2 clinical trials mark an important milestone in improving the current landscape of diabetes treatment. These results demonstrate that our three products provide better glycemic control compared to similar antidiabetic drugs. Over the years, we have successfully launched a full range of insulin products, from human insulin to insulin analogs, covering both basal and mealtime insulin, in the hope of comprehensively meeting the treatment needs of different diabetes patients. With recent breakthroughs in our research and development, we have also expanded our product portfolio with oral antidiabetic drugs, filling a gap in this critical area. Focusing on the frontiers of the endocrine field, we are actively promoting the development of new drugs, aiming to achieve comprehensive management of chronic metabolic diseases, including diabetes and obesity. Gan & Lee’s product portfolio currently covers next-generation insulin based on the extension to emerging metabolic disease targets, such as GLP-1 receptor agonists, supporting patients throughout their treatment journey with a view to driving changes in the management of diabetes and metabolic diseases and improving the quality of life of patients.” Forward-Looking Statements: These forward-looking statements are based on expectations and assumptions as of the date of this release. Due to various factors, actual results may differ significantly. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Reference 1. WANCAI XING, WEI CHEN, YINING ZHANG, JING GAO, ANSHUN HE, JUN ZHANG, YING DENG, FANGKAI XUE, YONGCHUN WANG, HAO FU, RUNYAO ZHANG, JINHUI HUANG, ZHONGRU GAN; 823-P: Molecular and Pharmacological Properties of GZR4, a Once-Weekly Insulin Analog. Diabetes 14 June 2024; 73 (Supplement_1): 823–P. https://doi-org.libproxy1.nus.edu.sg/10.2337/db24-823-P About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin ® ), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin ® ), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin ® 30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin ® 30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine ® ). In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine ® ) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. Further Information: BPRD@ganlee.com (Media) BD@ganlee.com (Business Development) info.medical@ganlee.com (Medical Information) SOURCE: Gan & Lee Pharmaceuticals

Clinical ResultPhase 2Drug Approval

15 Oct 2024

·www.prnewswire.com

Gan & Lee Pharmaceuticals' Three Innovative Drugs: GZR18 Injection, GZR4 Injection, and GZR101 Injection Achieve Primary Endpoints in Phase 2 Clinical Studies

After 24 weeks of treatment in patients with Type 2 diabetes, the bi-weekly GLP-1 receptor agonist GZR18 injection showed superior efficacy in lowering HbA1c and body weight compared to semaglutide (Ozempic®). After 16 weeks of treatment in patients with Type 2 diabetes, the once-weekly insulin analog GZR4 injection demonstrated superior HbA1c reduction in patients with uncontrolled diabetes on basal insulins, compared to insulin degludec (Tresiba®). After 16 weeks of treatment in patients with Type 2 diabetes, the premixed dual insulin analog GZR101 injection showed superior efficacy in reducing HbA1c and postprandial glucose compared to insulin degludec/insulin aspart (Ryzodeg®). BEIJING, Oct. 15, 2024 /PRNewswire/ -- Recently, Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that three of its independently developed drugs — the bi-weekly GLP-1 receptor agonist GZR18 injection, the once-weekly basal insulin analog GZR4 injection, and the premixed dual insulin analog GZR101 injection — successfully achieved positive results in three Phase 2 clinical trials conducted in adult patients with Type 2 diabetes (T2D) in China. In these studies, Gan & Lee's three innovative drugs demonstrated superior or comparable efficacy in lowering glycated hemoglobin (HbA1c) compared to the respective positive comparator drugs separately. Gan & Lee Pharmaceuticals' Diabetes Product Portfolio Diagram

Clinical ResultPhase 2

20 Aug 2024

·www.echemi.com

US Drug Price Slash Coming! 9 Drugs Cut in Half, Most Drastic Drop of 79%! But the Real Truth Behind It Is Heartbreaking

Recently, the United States has announced the first 10 drug prices after negotiations under the Inflation Reduction Act (IRA). Among these drugs, the price reduction for at least 9 of them is at least 50%. Among them, the reduction in the price of diabetes treatment drugs is particularly significant: Merck's Januvia price was reduced by 79%, from $527 per month to $113; Novo Nordisk's Fiasp, a treatment drug for type 1 diabetes, was reduced by 76%, from $495 per month to $119; AstraZeneca's Farxiga (dapagliflozin) was reduced by 68%. The First List of Drug Prices Negotiated under the US IRA Act Drug Name Original Price (Monthly) Negotiated Price (Monthly) Reduction Rate Januvia 527 113 0.79 Fiasp 495 119 0.76 Farxiga (Dapagliflozin) - - 0.68 According to a research report, the implementation of the first round of drug negotiations under the US IRA Act has resulted in price reductions ranging from 38% to 79% for the covered drugs. However, due to the fact that these drugs generally have a high list price and high rebate business model, it is expected that the negotiated price reduction will have a net impact on the actual product price of around 10% to 20%. Currently, these negotiated prices only apply to Medicare patients and not to patients with commercial insurance, thus having a limited short-term financial impact on the originator pharmaceutical companies. From a long-term perspective, the IRA negotiated price reduction may lead to a shorter peak return period for individual products, prompting pharmaceutical companies to be more inclined to develop drugs with broad indications as their initial indications. Considering the long R&D cycle, in the case of a shortened peak return period, large pharmaceutical companies may accelerate their acquisition and merger activities. Based on this, the research report maintains its "outperform" rating for the domestic innovative pharmaceutical industry and recommends actively following companies that have overseas commercialization or licensing potential. Analysis of the Impact of the First Round of Drug Negotiations under the US IRA Act Reduction in Drug Prices Impact of Net Price for Actual Products Target User Short-Term Financial Impact 38%-79% 10%-20% Medicare Patient Limited In fact, in recent years, the internationalization process of China's innovative drugs has been accelerating. For example, on August 9, Merck & Co., a multinational pharmaceutical company, announced that it plans to acquire CN201, a dual antibody drug in development by Tongrun Biotech, for up to $1.3 billion in total transaction value, which is intended for the treatment of cancer and autoimmune diseases. On June 14, Yasen Pharmaceuticals announced that it will license Orebactin (trade name: Nerivac) to Takeda, according to the agreement, Yasen Pharmaceuticals will receive a $100 million option payment, and is eligible to receive up to $1.2 billion in option exercise fees and additional potential milestone payments, as well as double-digit percentage royalties based on annual sales. According to industry statistics, in 2023, a total of 156 drugs were licensed out overseas, with a total transaction value of $35 billion, of which 78 projects belong to domestic enterprises going global. Entering 2024, the number of outbound licensing transactions is still growing. Just in the first half of this year, the pharmaceutical industry has seen more than 30 outbound License-out authorizations, involving small molecules, monoclonal antibodies, and other categories. On the commercialization front, by the end of 2023, a total of six innovative drugs developed in China had been approved for the US market, and the number of approvals has shown an upward trend, with the number of approvals from 2019 to 2023 being 1, 2, and 3. The Process of China's Innovative Pharmaceuticals Industry Going Global and Its Collaboration Event Involved Companies Transaction Amount Remarks Merck Acquires Tongrun Bio's Bispecific Antibody New Drug CN201 Merck, Tongrun Bio $1.3 Billion For the treatment of cancer and autoimmune diseases Ascentage Pharma Licenses Oregovomab to Takeda Ascentage Pharma, Takeda Up to $1.3 Billion Includes option payments, royalties and milestone payments Outbound Licensing of Chinese Drugs Domestic Companies $35 Billion 2023 data, 78 projects are outbound projects of domestic companies Innovative Drugs Listed in the US Market by China - - Number of approvals from 2019 to 2023 is 1, 2, 3 respectively The report indicates that collaborating to expand overseas markets is an ideal choice for Chinese pharmaceutical companies. For the internationalization of innovative drugs, the following factors should be given priority: the potential peak sales of the drug, innovative drugs with a larger number of patients in the target indications are likely to have higher peak sales; drugs with a smaller patient base even if approved, the elasticity of performance and market capitalization is relatively limited; the clinical efficacy and the order of marketing authorization, drugs with the potential of being the best-in-class or me-better are expected to capture a higher market share, and drugs with earlier marketing authorization have certain first-mover advantages; the strength of overseas partners, considering that the dominant force in global innovative drug commercialization is still traditional pharmaceutical giants, drugs licensed to these leading companies are expected to have higher peak sales. Companies worth paying attention to include Yifan Pharmaceutical, Maiwei Biotech, and Hengrui Pharmaceutical.

License out/inDrug Approval

100 Deals associated with Insulin aspart

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KEGG	Wiki	ATC	Drug Bank
D04475	Insulin aspart	A10AD05 A10AB05	DB01306

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	JP	Novo Nordisk A/S	20 Sep 2019
Diabetes Mellitus	EU	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	IS	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	LI	Novo Nordisk A/S	07 Sep 1999
Diabetes Mellitus	NO	Novo Nordisk A/S	07 Sep 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	ES	Novo Nordisk A/S	01 Apr 2005
Acute Lymphoblastic Leukemia	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Lymphoma	Phase 3	US	Novo Nordisk A/S	01 Apr 2004
Hypoglycemia	Phase 3	AU	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	HR	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	DK	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	IT	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	ZA	Novo Nordisk A/S	01 Sep 2001
Hypoglycemia	Phase 3	SE	Novo Nordisk A/S	01 Sep 2001
Diabetes, Gestational	Phase 3	US	Novo Nordisk A/S	01 Apr 2000

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04538352 (TRANSITION-T2D, CTgov)	Phase 4	Diabetes Mellitus, Type 2	60	Insulin Degludec+semaglutide+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	btsdlnzccn(mnetakeulh) = tzvjulksea eyzzvnegvr (qhuhyzoknm, csrpbozxik - trulvovzrr) View more	-	29 Jul 2024
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	btsdlnzccn(mnetakeulh) = ithnfmpohr eyzzvnegvr (qhuhyzoknm, rvtkvyyzey - tpbnwwuhay) View more
NCT04588259 (CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Diabetes Mellitus, Type 1	331	Insulin degludec+Faster aspart	tayysmpwpf(ojidbruzeu) = mtjxoamuqp yqktzenpqx (odrsqzfjbg, xcjxoyrikh - tqmoceanyr) View more	-	20 Mar 2024
NCT04460326 (In-FI, CTgov)	Phase 3	Diabetes Mellitus, Type 2	137	Insulin Glargine+NovoLog (Group 1 Insulin Glargine and Novolog)	bztafzikej(xojjbndvxi) = zhxzazwqrn oatfulupgf (iazftjnrdw, oxqwxcrsyy - ydpcfxczeq) View more	-	19 Mar 2024
				Insulin Glargine+Insulin Fiasp (Group 2 Insulin Glargine and Fiasp)	bztafzikej(xojjbndvxi) = fliqzrlqdw oatfulupgf (iazftjnrdw, gbxjjlufvs - cjltagrwcx) View more
NCT00913497 (CTgov)	Phase 4	Diabetes Mellitus, Type 1	16	insulin glulisine (Insulin Glulisine)	pigovzrtdn(pacdhqasuh) = kvjdkhmtyl ndtmbsivay (fhnohjsmpo, rodbaqhifm - baqidfepfw) View more	-	18 Sep 2023
				Insulin Aspart (Insulin Aspart)	pigovzrtdn(pacdhqasuh) = gdtbnxjdef ndtmbsivay (fhnohjsmpo, rsnplbndnx - dcmamqycso) View more
NCT03895515 (Pubmed)	Not Applicable	Diabetes Mellitus, Type 1	178	Fast-Acting Insulin Aspart	etmukcfdni(nvtqfgpyun) = fhnuankodh fqtvduuxaj (iscgmxpujo )	Positive	14 Jul 2023
CopenFast Trial (ADA2023)	Not Applicable	Diabetes Mellitus, Type 1	216	Faster-acting insulin aspart	lbeagxetqh(jpiolllkej) = blzslbelra oogmtfloji (gqvwchcobi, 38 - 46) View more	-	20 Jun 2023
				Insulin aspart	lbeagxetqh(jpiolllkej) = xlhjeecces oogmtfloji (gqvwchcobi, 39 - 46) View more
ADA2023	Not Applicable	-	29	AT247	pikwqylpfb(zelqisivqh) = qymnatghhd vcsmqqwqcf (pxzsfknwts )	-	20 Jun 2023
				NovoLog	pikwqylpfb(zelqisivqh) = giwhexltdi vcsmqqwqcf (pxzsfknwts, *)
NCT03262116 (CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	20	Insulin (Insulin-only Bionic Pancreas With BC222 Lispro)	jibaypmpwt(obxgnrrfih) = figexalogq wlehagrhtf (dsrpgxdmrp, hdxeatxwcf - ntetkqffou) View more	-	09 Dec 2022
				Insulin (Insulin-only Bionic Pancreas With Insulin Lispro)	jibaypmpwt(obxgnrrfih) = ieytcmykww wlehagrhtf (dsrpgxdmrp, vqoqamotgx - mndtolkenj) View more
NCT02408120 (Pubmed)	Phase 4	Diabetes Mellitus, Type 2	226	Intensive sliding scale insulin treatment	oleaxmyrbt(kcswskcmjp) = fvbgcsokzs difmkbvrmg (sfwnmoyork )	-	08 Jun 2022
				Nonintensive sliding scale insulin treatment	oleaxmyrbt(kcswskcmjp) = ozbzpbnzjc difmkbvrmg (sfwnmoyork )
ADA2022	Not Applicable	Diabetes Mellitus, Type 1	-	Fiasp and placebo with CC	tfsjtvgesc(obfvyyibqw) = linpkkkiot amrddsfqol (qusfldkjtj )	-	01 Jun 2022
				Fiasp and pramlintide with MA	tfsjtvgesc(obfvyyibqw) = yarvmfadza amrddsfqol (qusfldkjtj )

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis