The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is:
1. Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin?
2. Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled.
Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.

Start Date01 Oct 2025

Sponsor / Collaborator

Rutgers State University of New Jersey

NCT06999551

/ Not yet recruitingPhase 4

Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.

This study will have a single arm: the patient on NPH will continue his treatment for 4 weeks, at the end of the NPH treatment, the patient will receive his CGM device for three days for glycemic holter, a switch to insulin glargine is started for a period of 12 weeks with a dose adjustment and a control of the glycemic balance by CGM for three days at the end of the study.
The NPH insulin vial is a 10 ml vial dosed at 100 IU/mL, The Glargen vial is in the form of a solution for injection, a 3 ml vial dosed at 100 IU/mL

Start Date01 Jul 2025

Sponsor / Collaborator

Les Laboratoires des Médicaments Stériles

CTRI/2025/04/085669

/ Not yet recruitingPhase 4IIT

Comparative Efficacy and Safety of Glargine With Short-Acting Analog Versus NPH With Short-Acting Analog in Pulse Steroid Therapy-Induced Hyperglycemia - NIL

Start Date02 Jun 2025

Sponsor / Collaborator-

100 Clinical Results associated with Insulin glargine (Sanofi)

100 Translational Medicine associated with Insulin glargine (Sanofi)

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

3,345

Literatures (Medical) associated with Insulin glargine (Sanofi)

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of insulin icodec for the treatment of type 2 diabetes in Canada

Article

Author: Mau, Godfrey ; Garcia, David A. ; Singh, Sumeet ; Spence, Michaela ; Goldenberg, Ronald ; Jensen, Morten Sall

AIM:

Patients with type 2 diabetes (T2D) with poor glycemic control despite use of non-insulin agents can experience delay in initiating insulin therapy and poor adherence to insulin therapy, predominantly due to the burden of multiple injections^1-3. This study aimed to determine the cost-effectiveness of insulin icodec, first once-weekly basal insulin, compared with long-acting basal insulins for improving glycemic control in adults with T2D in Canada.

MATERIALS AND METHODS:

The Swedish Institute of Health Economics T2D Cohort Model was used to analyse three T2D groups: insulin naïve (IN), basal insulin experienced (BIE), and basal-bolus insulin experienced (BBIE). Comparators included insulin glargine, insulin detemir, and insulin degludec. Comparative efficacy was informed by the phase 3 ONWARDS trials of insulin icodec and network meta-analyses (NMA). Time horizon was 40 years. Analyses considered disutilities resulting from vascular complications, age, gender, diabetes duration, hypoglycemia, and injection burden. A 1.5% annual discount rate was used for costs and effects. The average cost per unit for each treatment, accounting for the market share of available formats and biosimilars was calculated. Outcomes were expressed as quality-adjusted life-years (QALYs) and cost-effectiveness as incremental cost utility ratios (ICUR [cost/QALY]).

RESULTS:

In all analyses, insulin icodec dominated insulin degludec and insulin detemir. Compared to insulin glargine U100 and U300, insulin icodec was associated with ICURs of $17,876, $20,844, and $73,253; and $6,439, $8,623, and $45,433 in the IN, BIE, and BBIE populations, respectively.

LIMITATIONS:

Limitations of this economic evaluation include the lack of data for some treatments in certain NMAs, uncertainty regarding the use of the NMA results for a 40-year time horizon, heterogeneous sources of disutilities, and uncertainty regarding the HRQoL benefits of reduced injection frequency.

CONCLUSIONS:

Insulin icodec is a cost-effective treatment option for adult patients with T2D versus once daily basal insulin-analogues publicly reimbursed in Canada.

01 Oct 2025·DIABETES OBESITY & METABOLISM

Glycemic therapies and the risk of gastrointestinal adverse events in veterans with type 2 diabetes

Article

Author: Sarwal, Amara ; Wei, Guo ; Chakravartula, Akhil R. ; Katkam, Niharika ; Nevers, McKenna ; Takyi, Augustine ; Derington, Catherine G. ; Shen, Jincheng ; Greene, Tom ; Beddhu, Srinivasan ; Hartsell, Sydney E. ; Boucher, Robert E. ; Singh, Ravinder ; Drakos, Stavros G.

Abstract:

Aims:

To compare the risk of gastrointestinal adverse events in new users of glucagon‐like peptide‐1 receptor agonists (GLP‐1RA), sodium‐glucose cotransporter‐2 inhibitors (SGLT2i) and insulin glargine.

Materials and Methods:

We conducted an active comparator, new user design study in veterans with type 2 diabetes who initiated one of these drug classes between 1 January 2018 and 31 December 2021 (N = 141 080). Inverse probability weighted Cox regression models were used to relate drug class to outcomes of gastroparesis, intestinal obstruction, gallstones, acute cholecystitis, acute pancreatitis and all‐cause death.

Results:

There were 19 765 (14.0%) veterans initiated on GLP‐1RA, 75 058 (53.2%) on SGLT2i and 46 257 (32.8%) on insulin glargine. Compared to SGLT2i, GLP‐1RA had a higher hazard of gastroparesis (HR 1.65, 95% CI 1.33–2.05) but a similar mortality hazard. Compared to insulin glargine, GLP‐1RA had a higher hazard of gastroparesis (HR 1.24, 95% CI 1.02, 1.52), but a lower hazard of all‐cause death (HR 0.62, 95% CI 0.58, 0.66). Compared to SGLT2i, insulin glargine had a higher hazard of gastroparesis (HR 1.29, 95% CI 1.07, 1.56), intestinal obstruction (HR 1.26, 95% CI 1.11, 1.43) and all‐cause death (HR 1.58, 95% CI 1.50, 1.65). Risks of gallstones, acute cholecystitis and pancreatitis were similar across the classes.

Conclusions:

In patients with type 2 diabetes at risk for gastroparesis, SGLT2i might be the preferred agent. In patients for whom SGLT2i is not an option or another agent is needed, patients and providers might need to weigh the higher risk of death with insulin glargine against the higher risk of gastroparesis with GLP‐1RA.

01 Oct 2025·DIABETES OBESITY & METABOLISM

Long‐term effectiveness of iGlarLixi treatment in people with type 2 diabetes in the United States: The soli‐durability 24‐month observational study

Article

Author: Malik, Rayaz A. ; Li, Xuan ; Lauand, Felipe ; Alvarez, Agustina ; Khunti, Kamlesh ; Adaş, Mine ; Anderson, John ; Amani, Mohammed E. A. ; Russo, Giuseppina

Abstract:

Aim:

To evaluate the effectiveness and safety of a fixed‐ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) over 24 months in people with type 2 diabetes (T2D).

Methods:

In this retrospective, observational study, data were collected from the Optum Market Clarity® database in the United States. People with T2D aged ≥18 years, previously treated with oral antidiabetic drugs ± basal insulin or glucagon‐like peptide‐1 receptor agonists, who initiated iGlarLixi between 1 January 2017 and 31 March 2020 and received ≥1 iGlarLixi prescription were included. The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, achievement of HbA1c <7%, change in body weight and rate of hypoglycaemia (defined as inpatient or outpatient claims, or blood glucose <70 mg/dL) every 3 months over 24 months.

Results:

In total, 1685 people were included in this analysis (mean age, 58.4 years; 52.6% female). In the overall population, including imputed values, mean ± standard deviation (SD) baseline HbA1c (9.3 ± 1.8%) was reduced by 0.9% to 8.3 ± 1.8% at 24 months. A HbA1c target of <7% was achieved in 22.2% of people at 24 months. Mean ± SD body weight remained stable from baseline (102.1 ± 24.2 kg) to 24 months (101.9 ± 23.3 kg). The hypoglycaemia event rate was 16.1 per 100 person‐years (P100PY) at baseline and decreased to 11.4 P100PY at 24 months.

Conclusions:

iGlarLixi initiation was associated with improved glycaemic control, without body weight change or increased hypoglycaemia over 24 months.

162

News (Medical) associated with Insulin glargine (Sanofi)

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

31 Jul 2025

·www.biospace.com

Sanofi Confident Tariffs Will Have Limited Impact on Finances in 2025

iStock, wildpixel For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU. Sanofi CFO François Roger has expressed confidence that tariffs will have little impact on the company in 2025. Speaking on Sanofi’s second-quarter results earnings call, Roger said it is difficult to predict the impact because of uncertainty about what actions the White House will take. The trade deal with the European Union establishes a 15% tariff on imports from Europe, where Sanofi is based, but CEO Paul Hudson told investors it remains unclear whether “it’s a 15% tariff with a caveat or a 15-plus or a 15-less.” Amid the uncertainty, Sanofi has run various scenarios based on the proposals reported in the media to understand how tariffs could affect finances in 2025. The models suggest Sanofi has little to fear for now. “We did not factor it in our guidance, but it will have a limited impact on 2025 because we already have inventory in place in the U.S.,” Roger said. “With what we know today and what we read in the media, we don’t think that it will impact our guidance in any way for 2025.” Hudson fielded a broader question about tariffs, Most Favored Nation pricing and the balance in funding for innovative drugs between the U.S. and Europe. Hudson said nobody knows what will happen but Sanofi is prepared for delivering guidance this year, “so don’t feel we’re casual about it because we’re absolutely not.” President Donald Trump has accused other countries of freeloading, fueling debate about differences in drug prices and healthcare spending between the U.S. and EU. Hudson made the case for EU countries putting in place the budgets to ensure patients can access innovative therapies. “There’s a lot of people who could contribute to economies and GDP if medicines were made available to them,” Hudson said. “I’m as interested in budgets for health giving access to innovation for more patients as I am in the price conversation. We will see where it nets out. As a healthcare company, we’d like to see more patients get access.” Hudson was speaking after Sanofi reported 10.1% sales growth at a constant exchange rate in the second quarter. The growth led Sanofi to predict a high single-digit percentage increase in sales for the full year. Sanofi’s revised forecast narrows its 2025 outlook at the top end of the previously predicted mid-to-high single-digit range. Dupixent drove growth in the second quarter. Supported by its launch in chronic obstructive pulmonary disease, Dupixent sales grew more than 20% to 3.8 billion euros ($4.3 billion). Sales of three of Sanofi’s other main medicines—Lantus, Toujeo and Praluent—grew by 10% or more. Sanofi attributed the growth in sales of the long-acting insulin Lantus to windfall sales due to the unavailability of competing medicines. Sales of nine newly launched medicines and vaccines rose 47.3%. Hemophilia A therapy Altuviiio led the way with revenues of 291 million euros ($333 million), an increase of more than 90% over the second quarter of 2024. Sanofi said growth of Altuviiio, which the FDA approved in 2023, was driven by patients switching from older plasma-derived and recombinant factor medicines and to a lesser extent from non-factor drugs.

Drug 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	European Union	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Iceland	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Liechtenstein	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus	Norway	Sanofi-Aventis Deutschland GmbH	09 Jun 2000
Diabetes Mellitus, Type 1	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000
Diabetes Mellitus, Type 2	United States	Sanofi-Aventis U.S. LLC	20 Apr 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	United States	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Argentina	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Brazil	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Canada	Sanofi	01 Apr 2008
Acute myocardial infarction	Phase 3	Mexico	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	United States	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Argentina	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Brazil	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Canada	Sanofi	01 Apr 2008
Diabetic Coma	Phase 3	Mexico	Sanofi	01 Apr 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04980027 (SAFEGUARD Study, Pubmed \| Diabetes Ther)	Phase 4	Diabetes Mellitus, Type 2	220	Insulin Glargine 300 U/ml	chxhxywjlg(lhuphtkvrn) = zvvkizyidk mqfzkildto (lloaevdavo ) View more	Positive	08 May 2025
NEWS Manual	Not Applicable	Diabetes Mellitus, Type 2	568	甘精胰岛素U300 (初治)	quoooxdgad(sqwxfrbvbm) = dtrusjalop tyjvqfztoi (igviqrekvt ) View more	Positive	19 Nov 2024
				甘精胰岛素U300 (基础胰岛素转换)	quoooxdgad(sqwxfrbvbm) = nkjbndhjga tyjvqfztoi (igviqrekvt ) View more
NCT03406000 (TOP1, Pubmed)	Phase 4	Diabetes Mellitus, Type 1	-	Twice-daily basal insulin	jsrdwjjhua(zygdspdxti) = dyuoxxsjag frapdrpezb (brhddhwkof ) View more	Positive	09 Jul 2024
NCT05109520 (Pubmed \| Diabetes Technol Ther)	Not Applicable	Diabetes Mellitus, Type 1	-	Insulin Glargine 300 U/mL (Gla-300)	cqmochzvri(svknmqvive) = pnyavlsahs okgizibxuc (adrjfzbeul, -0.16 to 0.07) View more	Positive	01 Jul 2024
				First-generation long-acting insulins	cqmochzvri(svknmqvive) = cvattjzrdo okgizibxuc (adrjfzbeul, 0.02 - 0.015)
NCT03703869 (Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2	412	Insulin Glargine U300 (Gla-300)	lqxzjkozfz(chivinqubo) = PROs improved dkazjejxbr (xvebtzyfvj ) View more	Positive	01 Mar 2024
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Metformin+Exenatide	vijbfmkfqs(apdkubqazz) = yyvbwaoevd bvbtyrzkry (nbbxxrrpkv, 7.89) View more	-	29 Dec 2023
NCT03874715 (GEMELLI X, CTgov)	Phase 3	Diabetes Mellitus, Type 1	210	Insulin glargine U100+Insulin Aspart SAR341402 (Switching: NovoLog/SAR341402)	naztxebcqg(dkxjztxviz) = ivpqiqyeix nrhfxgeedy (vjrwmouqxc, 18300) View more	-	21 Jul 2023
				Insulin glargine U100+Insulin Aspart (Non-switching: NovoLog)	naztxebcqg(dkxjztxviz) = qbjqeystdj nrhfxgeedy (vjrwmouqxc, 6530) View more
NCT01794143 (GRADE, ASN2022)	Phase 3	Diabetes Mellitus, Type 2	-	Sitagliptin	iunlzelmns(hvpszfmgct) = oioqhttmcr izmizneqxi (jwbepdnsko, -2.20 to -1.86)	Negative	03 Nov 2022
				Glimepiride	iunlzelmns(hvpszfmgct) = pxhkuhgkfm izmizneqxi (jwbepdnsko, -2.08 to -1.75)
NCT03703869 (ATOS, EASD2022)	Not Applicable	Diabetes Mellitus, Type 2	3,651	insulin glargine 300 U/mL (No/minimal titration (0-2 U))	qveofqlmgp(teviodamhz) = wcxrelgkcb ovhedqwogx (ymcurfrupo ) View more	Positive	20 Sep 2022
				insulin glargine 300 U/mL (2-6 U)	qveofqlmgp(teviodamhz) = szcmxrzjxk ovhedqwogx (ymcurfrupo ) View more
NCT04567225 (CTgov)	Phase 4	Diabetic Ketoacidosis \| Diabetes Mellitus, Type 1 \| Diabetes Mellitus, Type 2	39	IV insulin infusion+Early Glargine (Early Glargine)	zxtwhzlaaz(mwjccmzahl) = bgvosdlzom qsppjvbcyv (dxerycmscf, qahjinqyrg - lwfwkbybyj) View more	-	25 Aug 2022
				IV insulin infusion+Late Glargine (Standard Practice (Late Glargine))	zxtwhzlaaz(mwjccmzahl) = pnbgghsisi qsppjvbcyv (dxerycmscf, wjpovpcvmq - vlbjgakltk) View more

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