Single-center, double-blind, random-sequence study assessing the HDV dose-response relationship to Endogenous Glucose Production (EGP), Free Fatty Acids (FFA) and Glucose Disposal Rate (GDR) during a euglycemic clamp procedure following overnight stabilization of blood glucose with intravenous insulin (and, if needed intravenous glucose). EGP and GDR will be determined using established radioisotope methodology. The concentration of Hepatic Directed Vesicles (HDV) in the insulin lispro (LIS) infused during the clamp procedure will be varied such that the percentage of HDV-bound LIS will range from 0%, 1%, 10%, and 100%. Each participant will thus undergo four clamp procedures at the four different HDV levels. LIS will be infused at a constant dose (6 mU/m2/min) for each of the four procedures.

Start Date01 Feb 2025

Sponsor / Collaborator

University of California San Diego

[+1]

NCT06624956 / Not yet recruitingPhase 4IIT

Prevention and Treatment of Common Hyperglycemia in Surgery (PATCHS): a Randomized, Controlled, Pilot Study

The PATCH pilot trial aims to establish feasibility and determine the sample size of a future, large-scale, multi-site RCT, as well as reinforce the long-standing known safety profile of glucose, insulin, and potassium (GIK) and explore the physiologic response. We hypothesize that the use of GIK in non-diabetic patients undergoing abdominal surgery, will reduce rates of morbidity & death compared to standard of care treatment. In brief, primary outcomes of interest include estimation of the standard deviation (to derive a sample size estimation) and the ability to recruit target population, assessment of patient compliance/burden, and assessment of provider compliance/burden (feasibility).

Start Date01 Oct 2024

Sponsor / Collaborator

University of Washington

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

100 Clinical Results associated with Insulin lispro

100 Translational Medicine associated with Insulin lispro

100 Patents (Medical) associated with Insulin lispro

1,237

Literatures (Medical) associated with Insulin lispro

01 Nov 2024·DIABETES CARE

A Glycemic Threshold Above Which the Improvement of β-Cell Function and Glycemia in Response to Insulin Therapy Is Amplified in Early Type 2 Diabetes: The Reversal of Glucotoxicity

Article

Author: Ye, Chang ; Emery, Alexandra ; Kramer, Caroline K. ; Pu, Jiajie ; McInnes, Natalia ; Harris, Stewart B. ; Zinman, Bernard ; Retnakaran, Ravi ; Reichert, Sonja M. ; Gerstein, Hertzel C.

OBJECTIVE:

Alleviation of unrecognized glucotoxicity, with resultant recovery of β-cell function, could amplify the glucose-lowering effect of pharmacotherapy and contribute to the variable therapeutic response observed among patients with type 2 diabetes (T2D). However, clinical evidence supporting this concept is lacking. Short-term intensive insulin therapy (IIT) can ameliorate glucotoxicity and improve β-cell function in early T2D. Thus, for evidence of recovery of glucotoxicity-associated β-cell dysfunction, we sought to determine whether there exists a baseline fasting glucose threshold above which the post-IIT improvement in both β-cell function and glycemia is amplified.

RESEARCH DESIGN AND METHODS:

IIT (glargine, lispro) was administered for 3 weeks to 108 adults with T2D (mean duration 1.8 ± 1.4 years). Oral glucose tolerance tests before and after IIT enabled assessment of β-cell function by Insulin Secretion-Sensitivity Index-2 and insulinogenic index/HOMA-insulin resistance. For each level of baseline fasting glycemia from 6.0 to 10.5 mmol/L, we modeled the difference in IIT-induced percentage change in β-cell function between those at/above the indicated glucose level and those below it.

RESULTS:

The relationship between baseline fasting glucose and the differential change in β-cell function was nonlinear. Instead, this relationship was best fit by a cubic regression model with inflection (amplification) at fasting glucose at 9.3 mmol/L. Moreover, baseline fasting glucose at 9.3 mmol/L also identified the inflection point at which nonlinear reductions in fasting glucose and 2-h glucose, respectively, were both amplified.

CONCLUSIONS:

The respective improvements in β-cell function and glycemia in response to short-term IIT are amplified in those in whom baseline fasting glucose exceeds a defined threshold, consistent with reversal of glucotoxicity.

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.

01 Oct 2024·DIABETES OBESITY & METABOLISM

ADO09, a co‐formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes

Article

Author: Chan, You‐Ping ; DeVries, J. Hans ; Gaudier, Martin ; Heise, Tim ; Seroussi, Cyril ; Eloy, Rosy ; Andersen, Grit ; Riddle, Matthew ; Mégret, Claire ; Soula, Olivier

Abstract:

Aim:

To study safety, efficacy and weight loss with ADO09, a co‐formulation of insulin A21G and pramlintide, in type 1 diabetes.

Materials and Methods:

A randomized, two‐arm ambulatory 16‐week study compared ADO09 with insulin lispro in 80 participants with type 1 diabetes. We compared changes of weight, glycated haemoglobin, glycaemic patterns during continuous glucose monitoring, and insulin doses at baseline and at the end of treatment.

Results:

A significant and continuing weight loss, the primary endpoint, was observed with ADO09 compared with lispro as prandial insulin. In the whole group, the weight loss with ADO09 relative to lispro was 2.1 kg. Glycaemic control was relatively good (7.7% mean glycated haemoglobin) in both groups and did not change during treatment. Prandial insulin doses were reduced by 21% in the ADO09 group, whereas basal insulin dosage was not modified. Gastrointestinal symptoms were more frequent with ADO09, but no clear difference in hypoglycaemia was observed.

Conclusions:

These results extend previous observations on the efficacy and safety of this insulin/pramlintide co‐formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia.

News (Medical) associated with Insulin lispro

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

23 Sep 2024

·www.businesswire.com

AHF Praises FTC Lawsuit Targeting Largest PBMs Over Insulin Pricing

WASHINGTON--( BUSINESS WIRE )-- AIDS Healthcare Foundation (AHF) applauds the U.S. Federal Trade Commission (FTC) for taking decisive action against pharmacy benefit managers (PBMs) that drive up costs for insulin, a product never intended to generate financial windfalls. The original developers of insulin deemed it unethical to profit off the life-saving therapeutic, selling the patent to the University of Toronto for just $1 in 1923 . For the last 25 years, PBMs decided to make a once relatively inexpensive drug a significant part of their revenue streams. Thanks to the FTC, the three largest PBMs – Caremark Rx, OptumRx, and Express Scripts – will face legal consequences for their anticompetitive abuses involving insulin. As recently as 1999, the average cost of Humalog, a brand name insulin, cost just $21 . Instead of allowing millions of vulnerable diabetics to access their medication with financial ease, PBMs saw a revenue opportunity. The drug middlemen rigged their formularies, steering patients to higher priced insulin when cheaper alternatives were readily available. The result of PBM efforts to maximize profits through rebates skyrocketed the price of Humalog to $274 by 2017. AHF knows firsthand how PBM middlemen manipulate the prescription drug supply chain at the expense of independent pharmacies. PBMs exploit their privileged position by steering Americans toward more expensive medications, all to make more money. The sticker shock many Americans confront at the pharmacy counter is no accident. PBMs made a choice, putting profits over the health outcomes of the medically underserved. AHF welcomes the continued efforts by FTC Chair Khan to punish drug supply chain middlemen for their litany of abusive business practices. AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 2.1 million individuals across 47 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. To learn more about AHF, visit us online at AIDShealth.org , find us on Facebook , and follow us on Instagram , Twitter , and TikTok .

Patent Infringement

20 Sep 2024

·www.biopharmadive.com

FTC sues major pharmacy benefit managers over insulin prices

Dive Brief:The Federal Trade Commission has filed suit against the three largest pharmacy benefit managers in the country for anticompetitive business practices that artificially inflated the price of life-saving insulin drugs.The agencys administrative complaint alleges CVSCaremark, Cignas Express Scripts and UnitedHealths Optum Rx steered patients toward higher priced insulin to bring in larger rebates from pharmaceutical manufacturers.As a result, patients who werent eligible for the lower discounted price faced higher costs, the FTC alleges. Caremark, Express Scripts and Optum Rx together control about 80% of U.S. prescriptions.Dive Insight:The FTCs long-awaited lawsuit comes as tensions rise between PBMs, middlemen in the drug supply chain, and the lawmakers and regulators looking to crack down on U.S. drug prices.The companies have abused their economic power by rigging pharmaceutical supply chain competition in their favor, forcing patients to pay more for life-saving medication, the FTC said.The agencys complaint hinges on how PBMs have negotiated discounts for insulin medications with drugmakers.Pharmaceutical companies pay PBMs to have their medications placed on a favorable tier of the formulary, or list of covered drugs. According to PBM critics, that structure incentivizes the middlemen to prefer drugs with higher list prices, resulting in higher consumer costs.In 1999, the average list price of Eli Lillys brand-name insulin, Humalog, was $21, according to the FTC. But due in part to PBMs rebating practices, Humalogs list price increased to more than $274 by 2017, the complaint alleges. Meanwhile, PBMs collected billions of dollars in rebates.In a statement, Rahul Rao, the deputy director of the FTCs Bureau of Competition, called Caremark, Express Scripts and Optum Rx medication gatekeepers that extracted millions of dollars off the backs of patients who need life-saving medications.The FTCs administrative action seeks to put an end to the Big Three PBMs exploitative conduct, Rao continued.The FTC also names group purchasing organizations owned or affiliated with the three PBMs Zinc Health Services, Ascent Health Services and Emisar Pharma Services as defendants.Express Scripts, Caremark and Optum Rx decried the FTCs lawsuit on Friday.The action is based on a profound misunderstanding of how drug pricing works, according to an Optum Rx spokesperson, and is simply wrong, a Caremark spokesperson said.Andrea Nelson, Cignas chief legal officer, slammed the FTCs lawsuit as an unsubstantiated and ideologically-driven attack.The fact is that in the unlikely event the FTC succeeds in its suit and forces PBMs to include drugs on formulary even if they have higher net costs for plan sponsors and regardless of whether they are clinically necessary the FTC will drive drug prices higher in this country, Nelson said in a statement.PBMs maintain that they pass through the majority of rebate savings to their clients, and save customers money overall by negotiating down the price of drugs. Instead, the industry has attempted to refocus blame on drugmakers, arguing the core problem behind unaffordable U.S. drugs are the list prices set by manufacturers.The FTC noted PBMs arent the only problematic companies. The Bureau also remains deeply troubled by the role drug manufacturers like Eli Lilly, Novo Nordisk, and Sanofi play in driving up list prices of life-saving medications like insulin. Indeed, all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns, the agency said in a statement.Speculation the FTC would sue the companies started in mid-July,after the FTC released an interim reporton the status of its yearslong investigationinto the PBM industry.Express Scripts sued the FTC over the report on Tuesday, arguing it was defamatory and damaging to the PBMs business.Regulators and lawmakers in Washington have been more aggressive in cracking down on profiteering in the healthcare industry.Congress appeared poisedto curb some PBM practices last year, including forcing the companies to disclose more information about their negotiation practices to their employer and health plan clients. The push failed to materialize in any passed legislation. Still, lawmakers have held a number of hearings this year, including one over the summer in the House Oversight Committee where representatives on both sides of the aisle were highly critical of the drug middlemen.PBMs have also faced a number of recent lawsuits over their alleged contribution to rising costs, including from state attorneys generaland independent pharmacies. '

Patent Infringement

100 Deals associated with Insulin lispro

External Link

KEGG	Wiki	ATC	Drug Bank
D04477	Insulin lispro	A10AB04 A10AD04 A10AC04	DB00046

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	IS	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	LI	Eli Lilly Nederland BV	30 Apr 1996
Diabetes Mellitus	NO	Eli Lilly Nederland BV	30 Apr 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperglycemia	Phase 3	US	Eli Lilly & Co.	01 Mar 2011
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	US	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	AR	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	AU	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	BE	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	BR	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	CA	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	DK	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	GR	Eli Lilly & Co.	01 Nov 2010
Diabetes Mellitus, Noninsulin-Dependent, Type 4	Phase 3	HU	Eli Lilly & Co.	01 Nov 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04200313 (Insulin-Only Bionic Pancreas Trial, CTgov)	Not Applicable	Diabetes Mellitus, Type 1	440	Usual Care (UC)	ploadwgupg(puqzkzcecc) = bcfcixepbr hxcrknbxho (bzdokplrde, ooqcaghtqp - zyvdretyyd) View more	-	07 Nov 2023
NCT05262387 (EASD2023)	Phase 1	Diabetes Mellitus, Type 1	-	Ultra rapid lispro (URLi)	vxfyidavtg(jbrtymtprm) = nbpyhhjnrz uakhdoxuah (nnmvpkgavm )	Positive	03 Oct 2023
				Lispro	vxfyidavtg(jbrtymtprm) = ekjsyzycqy uakhdoxuah (nnmvpkgavm )
NCT04605991 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	176	Ultra rapid lispro (URLi)	uojwoyutnd(nihyvvvswq) = gifknhhthp lgazlfkqcu (zgtspgsvqt ) View more	-	07 Apr 2023
NCT04605991 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	187	Insulin Glargine+LY900014	azkeqrwpoo(sjyhgddfjp) = qmynrjduqk hkjmxihlme (lcuhgyuenu, ljuwoknuoo - bntmgscoeu) View more	-	03 Mar 2023
NCT03952130 (CTgov)	Phase 3	Diabetes Mellitus, Type 1	354	insulin glargine+Insulin Degludec+Insulin Lispro (Insulin Lispro (Humalog))	taivkfayht(axblodyjnh) = mwicsmlkgu bgvezcnscg (jqavqjcepr, dajkceagjn - liaurnahit) View more	-	08 Feb 2023
				insulin glargine+Insulin Degludec+LY900014 (LY900014)	taivkfayht(axblodyjnh) = mrdbvrscov bgvezcnscg (jqavqjcepr, hamtcelqzb - zhjlximtva) View more
NCT03262116 (CTgov)	Phase 2/3	Diabetes Mellitus, Type 1	20	Insulin (Insulin-only Bionic Pancreas With BC222 Lispro)	jfcnipxjei(ddqyneukbf) = hwctkcrpvi gfhhexpyur (xslocnkbsh, hwrvwzyuus - kzioodzdvp) View more	-	09 Dec 2022
				Insulin (Insulin-only Bionic Pancreas With Insulin Lispro)	jfcnipxjei(ddqyneukbf) = lezaithqdn gfhhexpyur (xslocnkbsh, zzlihtusnq - lbcotdezir) View more
NCT03214380 (PRONTO-T2D, Pubmed)	Phase 3	Diabetes Mellitus, Type 2	933	Ultra-rapid lispro	igzpsosyfl(ouhynkzqzi) = ykkztwczjj tmpjsgrymf (kqhnfowjzf )	Positive	04 Jul 2022
				Lispro (Humalog®)	igzpsosyfl(ouhynkzqzi) = dfggpxckgm tmpjsgrymf (kqhnfowjzf )
NCT01613807 (CTgov)	Phase 4	Diabetes, Gestational	40	insulin lispro (Mix 50/50)	tctacdqbmn(rhulgflovz) = yojirnsxxz mnnpwldpuv (rtzisgfycd, gvpfqqpxxu - cykdmbvruy) View more	-	08 Jun 2022
				Insulin (Usual Insulin Regimen)	tctacdqbmn(rhulgflovz) = trmmirlwly mnnpwldpuv (rtzisgfycd, nygkogfbke - skvkhfcict) View more

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