EFFICACY OF EARLY GLARGINE PLUS STANDARD IV INSULIN VERSUS STANDARD IV INSULIN IN PATIENTS WITH DIABETIC KETOACIDOSIS: A RANDOMISED CONTROLLED TRIAL - NIL

Start Date30 Sep 2024

Sponsor / Collaborator-

NCT06340854

/ Active, not recruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Start Date19 Apr 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06619301

/ RecruitingPhase 3IIT

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Start Date01 Apr 2024

Sponsor / Collaborator

Loyola University Medical Center

100 Clinical Results associated with Insulin glargine (Sanofi)

100 Translational Medicine associated with Insulin glargine (Sanofi)

100 Patents (Medical) associated with Insulin glargine (Sanofi)

2,168

Literatures (Medical) associated with Insulin glargine (Sanofi)

02 Jan 2025·EXPERT OPINION ON PHARMACOTHERAPY

Evaluating semaglutide + LAI-287 (IcoSema) for the treatment of diabetes mellitus type II

Review

Author: Davis, Stephen N. ; Siamashvili, Maka

INTRODUCTION:

A stepwise coordinated multiple therapeutic targeted approach to the treatment of type 2 diabetes includes starting with lifestyle modification, oral antihyperglycemic agents, non-insulin injectables (Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), and both short and long-acting insulins. Ultra-long-acting insulins offer more convenient administration. As in any chronic disease, the introduction of a novel medication must balance safety, efficacy, financial cost, as well as improved patient convenience and adherence.

AREAS COVERED:

This manuscript describes IcoSema - a new investigational fixed-ratio combination of basal insulin icodec and the GLP-1 RA semaglutide. The key trials from the clinical development process of insulin icodec, semaglutide, and IcoSema are reviewed with important endpoints highlighted.

EXPERT OPINION:

Once-weekly IcoSema offers glycemic efficacy that is non-inferior to glargine+aspart, similar risk of hypoglycemia, significant reduction in body weight, the convenience of use, and favorable safety profile with most adverse events being gastrointestinal.

01 Jan 2025·DIABETES OBESITY & METABOLISM

Effectiveness and safety of insulin glargine 300 U/mL in insulin‐naïve individuals according to diabetes duration: Results from the REALI European pooled data analysis

Article

Author: Gourdy, Pierre ; Vera, Carine ; Bonnemaire, Mireille ; Mauquoi, Celine ; Müller‐Wieland, Dirk ; Mauricio, Didac ; Bonadonna, Riccardo C. ; Freemantle, Nick

Abstract:

Aim:

To evaluate the effectiveness and safety of insulin glargine 300 U/mL (Gla‐300) initiation according to diabetes duration (DD).

Materials and Methods:

We analysed patient‐level data from 2381 insulin‐naïve individuals with type 2 diabetes (T2D), of whom 2349 (98.7%) were treated with Gla‐300 for 24 weeks. Of the 2381 participants, 1048 (44.0%) had a DD of less than 8 years and 1333 (56.0%) had a DD of 8 years or longer. We further analysed the subgroups of participants having a DD of less than 4 years (N = 450), 4‐8 years (N = 598), 8‐12 years (N = 627) and 12 years or longer (N = 706).

Results:

Mean ± standard deviation age was 60.2 ± 9.0 years in participants with a DD less than 8 years and 64.2 ± 8.8 years in those with a DD of 8 years or longer. At 24 weeks of Gla‐300 therapy, HbA1c improved with a least‐squares (LS) mean change from baseline of −1.88% (95% confidence interval [CI], −1.95 to −1.80) and −1.71% (95% CI, −1.77 to −1.65), respectively, resulting in a LS mean difference between groups of 0.17% (95% CI, 0.07 to 0.26; P = .0005). In the subgroup analysis, LS mean HbA1c reduction from baseline to week 24 was highest in participants with a DD of less than 4 years and lowest in participants with a DD of 12 years or longer. Overall, incidences of symptomatic and severe hypoglycaemia were low, irrespective of DD, without body weight changes.

Conclusions:

Gla‐300 was effective and safe in insulin‐naïve individuals with T2D, regardless of DD. Improvement in HbA1c was greater when Gla‐300 was initiated in participants with a DD of less than 4 years, although the difference between the groups was modest.

01 Jan 2025·ACADEMIC EMERGENCY MEDICINE

SQuID (subcutaneous insulin in diabetic ketoacidosis) II: Clinical and operational effectiveness

Article

Author: Cruz‐Bravo, Paulina ; Schneider, Ryan M. ; Ancona, Rachel ; Griffey, Richard T. ; Suarez, Dan ; Lehmkuhl, Michael ; Girardi, Margo ; Frawley, Laura ; Kaser, Taylor ; Yeary, Julianne ; LaRossa, Gina

Abstract:

Objective:

We previously demonstrated safe treatment of low‐ to moderate‐severity (LTM) diabetic ketoacidosis (DKA) using the SQuID protocol (subcutaneous insulin in DKA) in a non–intensive care unit (ICU) observation setting, with decreased emergency department length of stay (EDLOS). Here, we expand eligibility to include sicker patients and admission to a regular medical floor and collected more detailed clinical data in a near‐real‐time fashion.

Methods:

This is a real‐world, prospective, observational cohort study in an urban academic hospital (March 4, 2023–March 4, 2024). LTM DKA patients were treated with IV insulin (floor or ICU) or on SQuID. We compare fidelity (time to glargine and dextrose‐containing fluids), safety (rescue dextrose for hypoglycemia), effectiveness (time to anion gap closure, time on protocol), and operational efficiency (time to bed request, EDLOS, and ICU admission rate since implementation of the protocol).

Results:

Of 84 patients with LTM DKA, 62 (74%) of were treated with SQuID and 22 (26%) with IV insulin. Fidelity was high in both groups. Rescue dextrose was required in five (8%) versus four (18%) patients, respectively (difference 9%, −31% to 10%). Compared to the IV insulin group, time to anion gap was 1.4 h shorter (95% CI −3.4 to 0.2 h) and time on protocol was 10.4 h shorter (95% CI −22.3 to −5.0 h) in SQuID patients. Median EDLOS was lower in the SQuID cohort 9.8 h (IQR 6.0–13.6) than the IV floor cohort 18.3 h (IQR 13.4–22.0 h), but longer than the overall IV insulin cohort. Since inception of SQuID, ICU admission rate in LTM DKA has decreased from 54% to under 21%.

Conclusions:

In this single‐center study, we observed excellent fidelity, equivalent or superior safety, and clinical and operational effectiveness with SQuID compared to IV insulin. The SQuID protocol has become the de facto default pathway for treatment of LTM DKA. Since inception of SQuID, ICU admissions in LTM DKA have decreased 33%.

105

News (Medical) associated with Insulin glargine (Sanofi)

18 Dec 2024

·www.pharmaceutical-technology.com

Egyptian Drug Authority approves Lilly and EVA’s insulin injection

The collaboration of Lilly and EVA Pharma began in 2022 to provide affordable insulin. Credit: © 2022 Eva Pharma All Rights Reserved. Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection to treat type 1 and type 2 diabetic patients. EVA Pharma manufactures the injection in partnership with Lilly. The collaboration, which began in 2022, aims to provide quality, affordable insulin to a minimum of one million type 1 and type 2 diabetic individuals in low to middle-income countries (LMICs) annually, predominantly in Africa. In under two years, EVA Pharma then established a new biologics manufacturing facility, completed stability testing and finalised insulin formulations, along with gaining the regulatory approval secured for the insulin injection locally. Lilly has been instrumental in supplying its active pharmaceutical ingredient (API) for insulin at a low cost and offering technology transfer to EVA. This has enabled the local formulation, filling and finishing of insulin vials and cartridges. In parallel, EVA has submitted its insulin injection for local regulatory approval. The collaboration also includes efforts to achieve World Health Organization (WHO) pre-qualification for insulin injection, which would affirm the high-quality standards of EVA’s medicines as set by WHO. The initiative aligns with the Lilly 30×30 goal, which aspires to enhance access to quality healthcare for 30 million people in resource-limited settings every year by 2030. Lilly International president and executive vice-president Ilya Yuffa stated: “For more than a century, Lilly has been at the forefront of diabetes care, offering innovative solutions that make life better for people around the world. “Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. “ In September 2024, Lilly also agreed to license baricitinib manufacturing know-how to EVA, enabling the supply of treatments for immunological diseases in 56 LMICs across Africa. In a separate development, the China National Medical Products Administration (NMPA) approved Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion) for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment and mild dementia stage who have confirmed amyloid pathology. The NMPA application was supported by data from the Phase III TRAILBLAZER-ALZ 2 trial.

Drug ApprovalPhase 3

12 Nov 2024

·pipelinereview.com

Gan & Lee Pharmaceuticals Announced Positive Phase 1 Results for Its Oral GLP-1 Receptor Agonist GZR18 Tablet in Healthy Participants, Demonstrating 4.16% Weight Reduction in Two Weeks

BEIJING, China I November 12, 2024 I Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the positive topline results of a Phase 1 clinical trial its oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) GZR18 tablets in healthy participants in China. Statement: The Phase 1 clinical trial (CTR20240663) was a randomized, open-label, first-in-human study involving 92 participants, designed to assess the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GZR18 tablets in healthy adult participants. The study also evaluated the effect of meal timing on the drug’s PK, PD, safety, and tolerability. In this study, GZR18 tablets were safe and well-tolerated, with the most common adverse events being gastrointestinal reactions, consistent with the established safety profile of GLP-1 based therapies. PK data indicated favorable absorption, supporting a once-daily oral regimen. Both single and multiple doses showed a dose-response relationship in terms of PK and PD parameters. Participants treated with the target dose of 60 mg daily for two weeks exhibited an average weight reduction of 4.16% from baseline. Furthermore, a week after stopping treatment, subjects continued to lose weight 0.51%, reaching an average total reduction of 4.67% compared to baseline. At 21 days after discontinuation, neither the participants’ body weight nor BMI had returned to baseline values. About GZR18 Tablets GZR18 tablet is an investigational, once-daily oral GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals. It utilizes a small molecule absorption enhancer, SNAC (N-[8-(2-hydroxybenzoyl)amino] caprylate), to facilitate drug absorption in the stomach by resisting pepsin degradation, thus prolonging the drug’s half-life and enhancing its bioavailability. GZR18 tablets are currently in global Phase 1 clinical development. 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. SOURCE: Gan & Lee Pharmaceuticals

Phase 1Drug ApprovalClinical Result

12 Nov 2024

·www.prnewswire.com

Gan & Lee Pharmaceuticals Announced Positive Phase 1 Results for Its Oral GLP-1 Receptor Agonist GZR18 Tablet in Healthy Participants, Demonstrating 4.16% Weight Reduction in Two Weeks

After two weeks of treatment, GZR18 tablets resulted in an average weight reduction of up to 4.16%, with continued weight loss observed even after discontinuation. The pharmacokinetic profile supports a once-daily oral dosing regimen for GZR18 tablets. The safety and tolerability of GZR18 tablets align with the known safety characteristics of GLP-1 receptor agonists, with no unexpected safety signals during the study. BEIJING, Nov. 12, 2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the positive topline results of a Phase 1 clinical trial its oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) GZR18 tablets in healthy participants in China. Statement: GZR18 tablet is an ivestigational drug and has not yet been approved in China. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. The Phase 1 clinical trial (CTR20240663) was a randomized, open-label, first-in-human study involving 92 participants, designed to assess the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GZR18 tablets in healthy adult participants. The study also evaluated the effect of meal timing on the drug's PK, PD, safety, and tolerability. In this study, GZR18 tablets were safe and well-tolerated, with the most common adverse events being gastrointestinal reactions, consistent with the established safety profile of GLP-1 based therapies. PK data indicated favorable absorption, supporting a once-daily oral regimen. Both single and multiple doses showed a dose-response relationship in terms of PK and PD parameters. Participants treated with the target dose of 60 mg daily for two weeks exhibited an average weight reduction of 4.16% from baseline. Furthermore, a week after stopping treatment, subjects continued to lose weight 0.51%, reaching an average total reduction of 4.67% compared to baseline. At 21 days after discontinuation, neither the participants' body weight nor BMI had returned to baseline values. About GZR18 Tablets GZR18 tablet is an investigational, once-daily oral GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals. It utilizes a small molecule absorption enhancer, SNAC (N-[8-(2-hydroxybenzoyl)amino] caprylate), to facilitate drug absorption in the stomach by resisting pepsin degradation, thus prolonging the drug's half-life and enhancing its bioavailability. GZR18 tablets are currently in global Phase 1 clinical development. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 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. SOURCE Gan & Lee Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultDrug Approval

100 Deals associated with Insulin glargine (Sanofi)

External Link

KEGG	Wiki	ATC	Drug Bank
D03250	Insulin glargine (Sanofi)	A10AE04	DB00047

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	EU	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	IS	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	LI	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	NO	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus, Type 1	US	Sanofi-Aventis U.S. LLC	20 Apr 2000
Diabetes Mellitus, Type 2	US	Sanofi-Aventis U.S. LLC	20 Apr 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	US	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	AR	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	BR	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	CA	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	MX	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	US	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	AR	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	BR	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	CA	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	MX	Sanofi	01 Apr 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Diabetes Mellitus, Type 2	568	甘精胰岛素U300 (初治)	apzzyjnmqg(ylvlrdxwni) = uzraipftrv qmxpmccndm (pwpmazmxvu ) View more	Positive	19 Nov 2024
				甘精胰岛素U300 (基础胰岛素转换)	apzzyjnmqg(ylvlrdxwni) = acrxxyhhpd qmxpmccndm (pwpmazmxvu ) View more
NCT03406000 (TOP1, Pubmed)	Phase 4	Diabetes Mellitus, Type 1	-	Twice-daily basal insulin	btyptlwqis(whklabguth) = tsnicudzzh mztkxlnwjv (qbguyhijlk ) View more	Positive	09 Jul 2024
ISN WCN2024	Not Applicable	Diabetes Mellitus, Type 2 \| Kidney Failure, Chronic	11	NPH insulin	xrsgkzuuax(wqprkopdxy) = hxztmjhzft icottxqzrw (eaanpixnde, ±76.9)	Positive	01 Apr 2024
				Glargine insulin	xrsgkzuuax(wqprkopdxy) = ksfwbmxpit icottxqzrw (eaanpixnde, ±60.6)
NCT03703869 (Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2	412	Insulin Glargine U300 (Gla-300)	jewwznucuh(dixcyarmnj) = PROs improved bjhoupphtm (jhajpbiubb ) View more	Positive	01 Mar 2024
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Metformin+Exenatide	tuibkrurmh(cvzrdxfesc) = zjlyfsneor qmiuzbbkkm (qdaxtkpded, qnlqlujoju - nmzjmtduaw) View more	-	29 Dec 2023
EASD2023	Not Applicable	Diabetes Mellitus, Type 2	-	Insulin glargine 300 U/mL (Gla-300)	cvbywoizoq(hikylmrwqj) = klvgyenndb bcxezegdup (osflgftcgz )	-	05 Oct 2023
				Long-acting basal insulins (BIs)/NPH insulin	cvbywoizoq(hikylmrwqj) = tqvnfbnnwm bcxezegdup (osflgftcgz )
NCT00069784 (ORIGIN, ESC2023)	Phase 3	Sex hormone-binding globulin (SHBG) \| testosterone	-	Glargine	rqbvuaahyq(nqzderxegx) = ttaklkwliq dhgwyvqncs (hzsiaiydbq )	-	26 Aug 2023
				Glargine	rqbvuaahyq(nqzderxegx) = ttoklhhapm dhgwyvqncs (hzsiaiydbq )
NCT03874715 (GEMELLI X, CTgov)	Phase 3	Diabetes Mellitus, Type 1	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	jfgztyljad(rmcdeizjxv) = dwcowkksar ckpufhrnbb (qvlxoxizhr, ulgsvdtrte - umplyyaaqq) View more	-	21 Jul 2023
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	jfgztyljad(rmcdeizjxv) = odybgsitwi ckpufhrnbb (qvlxoxizhr, hadpzbslkg - ahcjcchcnf) View more
RESTORE-G (ADA2023)	Not Applicable	-	-	Glargine 300 U/mL	ntdtcmttnj(qwchzxdirz) = qiecgaswsi snpdlvwsvt (wjyqnnoqqq )	-	23 Jun 2023
ADA2023	Not Applicable	-	-	Bridging dose of G with first dose of D	dbtyahhdnw(rynyacaypj) = mtyfejgevr jwoufxfftp (lwogcrjgmd )	-	20 Jun 2023
				Placebo	ibnbftqkhy(wcnbwrhebn) = qsdsehpjsv kehhrdohfo (ufhicvwsig )

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