Humalog pen (insulin lispro) / Eli Lilly - LARVOL DELTA

ASSESSMENT OF ADHERENCE AND GLUCOSE CONTROL WHILE USING A CONNECTED INSULIN MANAGEMENT PLATFORM (ATTD 2025) - "The connected platform consisted of a Tempo Smart Button® attached to a Humalog® Tempo Pen™, Dexcom® G6 CGM, and Glooko® Clinical Research platform...MBD were meals without an insulin dose from 1 hour before through 1 hour after the start of a glucose excursion defined as a >70 mg/dL rise within 2 hours, not preceded by a value <70 mg/dL.Results The impact of the connected insulin platform on missed bolus doses, mistimed bolus doses, CGM metrics, HbA1c and patient reported outcomes on patients with type 1 and type 2 diabetes will be presented. The reasons for lack of glucose control during the study will also be presented.Conclusions This study provided insights into the use of a connected insulin platform in clinical practice for patients with type 1 and type 2 diabetes."

Adherence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

FIRST CLINICAL REPORT OF THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM BOLUS CALCULATOR USE IN FREE LIVING ENVIRONMENT (ATTD 2025) - "The Lilly Tempo Smart Button enables Basaglar®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. Use of the IC was consistent across all meals and corrections.Conclusions The aggregate glucose data indicates increased usage of the IC over the 6-week period corresponds to greater trust in the IC recommendations, as a significant percentage of administered doses were within 10% of the IC's suggested dose. Aggregate data indicates meaningful improvement in glycemic outcomes with the Tempo Platform IC over this period."

Clinical • Diabetes • Metabolic Disorders

Pharmacokinetics and pharmacodynamics of insulin lispro 25 versus the original preparation (Humalog®25) in Chinese healthy male volunteers. (PubMed, Front Pharmacol) - " Bio-equivalence between insulin lispro (R) (Humalog®25) and insulin lispro (T) was demonstrated, with both showing good tolerance in healthy Chinese volunteers. The results provide evidence supporting the interchangeability of different drug formulations and offer more options for clinical drug use."

Journal • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders

Is Brain Insulin Resistance a Feature of the Biology of Depression in Adolescents (clinicaltrials.gov) - P=N/A | N=24 | Active, not recruiting | Sponsor: Centre for Addiction and Mental Health | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Oral Anti Diabetic Agents in the Hospital (clinicaltrials.gov) - P4 | N=260 | Recruiting | Sponsor: Emory University | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Nov 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders

early onset Thiamine Responsive Megaloblastic Anemia (TRMA), diabetes mellitus and sensorineural hearing loss, in 7 month infant, case report (ESPE 2024) - "Patient was started on oral thiamine 30mg /day and vitamin D3 supplement as well as subcutaneous insulin titrated 0.3-0.5units/ kg/day (Insulin Glargine once daily and insulin Humalog (Lispro) 3-4 times daily with meals)... TRMA syndrome should be kept in mind especially in neonates and children presenting with a triad of megaloblastic anemia, diabetes mellitus and hearing impairment. Genetic analysis warranted to confirm the diagnosis. We believe that early genetic testing and establishment of thiamine treatment can correct anemia and accomplish euglycemia along with enhancement of the glycemic control."

Case report • Clinical • Anemia • Diabetes • Hematological Disorders • Metabolic Disorders • Otorhinolaryngology • Thrombocytopenia

A Study of LY8888AX in Participants Using a Connected Insulin Management Platform (clinicaltrials.gov) - P=N/A | N=36 | Completed | Sponsor: Eli Lilly and Company | N=100 ➔ 36 | Active, not recruiting ➔ Completed

Adherence • Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

START2: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) (clinicaltrials.gov) - P=N/A | N=430 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Diabetes • Gestational Diabetes • Metabolic Disorders

START 1: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (clinicaltrials.gov) - P=N/A | N=430 | Recruiting | Sponsor: Thomas Jefferson University | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Diabetes • Gestational Diabetes • Metabolic Disorders

A Randomized Controlled Trial of Three- and Seven-days Insulin Infusions Set (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Steno Diabetes Center Copenhagen

New trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY8888AX in Participants Using a Connected Insulin Management Platform (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Adherence • Enrollment closed • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

START2: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) (clinicaltrials.gov) - P=N/A | N=430 | Not yet recruiting | Sponsor: Thomas Jefferson University

New trial • Diabetes • Gestational Diabetes • Metabolic Disorders

START 1: Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (clinicaltrials.gov) - P=N/A | N=430 | Not yet recruiting | Sponsor: Thomas Jefferson University

New trial • Diabetes • Gestational Diabetes • Metabolic Disorders

A Study of LY8888AX in Participants Using a Connected Insulin Management Platform (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jun 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Adherence • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Successful Insulin Allergy Desensitization to Humalog During the Second Trimester of Pregnancy (ENDO 2024) - "Metformin and Jardiance, previously prescribed, were discontinued upon confirmation of her current pregnancy. This unique case demonstrates how insulin desensitization can be a safe and successful strategy to help achieve insulin tolerance and glycemic control during pregnancy. Election of an insulin, such as Humalog, that can achieve the one-hour post-prandial glucose target during pregnancy and also provide effective basal coverage should be considered as desensitization can only be done with one insulin type at a time.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

Allergy • Diabetes • Gestational Diabetes • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Unusual Case of Extreme Insulin Resistance in a Pregnant Patient with Type 1 Diabetes Mellitus (ENDO 2024) - "Her insulin requirements progressively increased and her regimen at week 31 was degludec 100 units three times daily, Humulin R U500 210 units/day in divided doses, and Humalog IC of 1:1, and CF of 1:5 with a target of 100 mg/dl, reaching up to 1100 units/day. Such a case has not been described in the literature before. Insulin requirements in patients with T1DM increase by 70% on average, however in this case they increased by around 150% even prior to the use of steroids. The change in insulin requirements is a combined effect of placental hormones and obesity."

Clinical • Diabetes • Endocrine Disorders • Genetic Disorders • Gynecology • Metabolic Disorders • Obesity • Obstetrics • Type 1 Diabetes Mellitus

Recognition of Need for Optimization of Diabetes Education for Children with Type 1 diabetes: Long term Provider Experience . (ENDO 2024) - "Case 2: The mother called at 9 pm and reported that by mistake, she did administer "Admelog" at 18 units instead of Basaglar, for her son, 11 year old with Type 1 diabetes. He was on Lantus and Humalog before... -Complications of Type 1 diabetes are preventable. The family needs further education on diabetes management including review of Insulin therapy when Insulin pump does malfunction, with a copy of written instruction of Insulin doses, differences in long and short acting Insulin along with psychosocial support to optimize care of children with Type 1 diabetes.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins."

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

The Sugar Saga: A Profound Case of Diabetic Ketoacidosis due to Enfortumab Vedotin (ENDO 2024) - "Patient was started on hydrocortisone 50mg every 6h and his blood glucose readings eventually normalized over a span of 1 week. Patient eventually was able to be discharged to rehabilitation with just a correctional humalog insulin...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • Diabetes • Genito-urinary Cancer • Metabolic Disorders • Oncology • Septic Shock • Solid Tumor • Urothelial Cancer

QWINT-4: A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (clinicaltrials.gov) - P3 | N=730 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Active, not recruiting | Sponsor: Mannkind Corporation | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2024 ➔ Sep 2024

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

FROM CLINICAL DATA TO CLINICAL INSIGHTS – TRANSFORMATIVE OPPORTUNITIES FOR CLINICAL CARE USING THE LILLY TEMPO PERSONALIZED DIABETES MANAGEMENT PLATFORM: A CLINICAL TUTORIAL (ATTD 2024) - "The Lilly Tempo Smart Button™ enables Basaglar ®, Humalog®, and Lyumjev® insulin dose-related data to automatically transfer to a compatible App. The Tempo system can provide the missing information to the HCPs to transform the guess work and difficult conversations with PwDs to an opportunity for personalized and precision medical advice and better experience to the PwDs and the HCPs."

Clinical data • Diabetes • Metabolic Disorders

ASSESSMENT OF PARTICIPANT ADHERENCE AND GLUCOSE CONTROL WHILE USING A CONNECTED INSULIN MANAGEMENT PLATFORM (ATTD 2024) - "The connected platform consists of a Humalog® Tempo Pen™, Dexcom® G6, Tempo Smart Button®, and Glooko® Clinical Research platform... Connected pens may support insulin management and help reduce missed bolus doses. A connected insulin management platform will allow the assessment of MBDs and other information related to the use of a connected platform.Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology Clinical practice guideline: the use of advanced technology in the management of persons with diabetes meiiltus."

Adherence • Diabetes • Metabolic Disorders

HIGH SATISFACTION WITH CONTROL-IQ 1.5 AND LYUMJEV INSULIN IN CHILDREN, ADOLESCENTS AND ADULTS WITH TYPE 1 DIABETES (ATTD 2024) - "Lyumjev in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 was safe with high treatment satisfaction compared to Humalog for adults and youth with T1D."

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

Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Centre for Addiction and Mental Health | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Metabolic Disorders • Psychiatry • Schizophrenia

Is Brain Insulin Resistance a Feature of the Biology of Depression in Adolescents (clinicaltrials.gov) - P=N/A | N=24 | Recruiting | Sponsor: Centre for Addiction and Mental Health | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry