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

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Stanford University | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. (clinicaltrials.gov) - P4 | N=76 | Completed | Sponsor: Medical University of Warsaw | Not yet recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Dec 2024

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog® (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Xentria, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Autoimmune Gastroparesis and Immune Thrombocytopenia-Effective Treatment With Immunomodulation (ACG 2025) - "She developed symptoms of nausea and vomiting which occurred in the August of 2019 and resulted in hospitalization where she was noted to have severe thrombocytopenia 12 K. Work up yielded a diagnosis of ITP and was started on IVIg and Prednisone taper over 8 weeks with excellent response...She recalls her diagnosis of Type 2 Diabetes mellitus predated her diagnosis of ITP by 1 year and after weight loss of 60 lbs (199 lbs to 139 lbs ), her hemoglobin A1c normalized and she was taken off Humalog and Triseba for diabetes...Her ITP relapsed in Aug of 2023 with shorter duration of response to Dexamethasone and so was started on pulse dose Dexamethasone and Rituximab weekly for 4 doses in October 2023 and her ITP went into remission till October 2024 when a repeat course of Dexamethasone and Rituxamab was administered for recurrent thrombocytopenia with good response. In early 2025, she was hospitalized with refractory vomiting and was started on pulse dose Dexamethasone and..."

Immunomodulating • CNS Disorders • Depression • Diabetes • Gastrointestinal Disorder • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Metabolic Disorders • Migraine • Psychiatry • Thrombocytopenia • Thrombocytopenic Purpura • Type 2 Diabetes Mellitus

Neonatal Diabetes Mellitus with Maternal Pembrolizumab Exposure: A Complex Interplay of Genetic and Autoimmune Factors (AAP-NCE 2025) - "Subsequent management involved injections of diluted insulin (U10 Humalog), maintaining target glucose levels of 200–250 mg/dL. The presented case highlights the critical diagnostic considerations involving NDM, autoimmune mechanisms, and genetics. This case shows the challenges of diagnosis and management of NDM. Recognition of ICIs like Pembrolizumab as potential inducers, combined with genetic mutations such as LRBA, is essential for accurate diagnosis and effective intervention of neonatal autoimmune disorders. Early comprehensive genetic evaluation and personalized management strategies remain crucial for optimizing outcomes in affected neonates."

IO biomarker • Breast Cancer • Diabetes • Endocrine Disorders • Hypoglycemia • Immunology • Metabolic Disorders • Rare Diseases • Solid Tumor

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog® (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Xentria, Inc.

New P1 trial

SPEED: Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Stanford University

New P1 trial • Diabetes • Metabolic Disorders • 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 | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • CNS Disorders • Metabolic Disorders • Psychiatry • Schizophrenia

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Oral Anti Diabetic Agents in the Hospital (clinicaltrials.gov) - P4 | N=260 | Recruiting | Sponsor: Emory University | Trial completion date: Jul 2025 ➔ May 2026 | Trial primary completion date: Jul 2025 ➔ Apr 2026

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

Nano-Amounts of Glucagon Premixed With Fast-Acting Insulin Lispro: Effect on Insulin Absorption in Pigs. (PubMed, Curr Ther Res Clin Exp) - "Nine pigs were included in the control groups; they received a subcutaneous injection of 10 U of insulin lispro (LyumjevⓇ or HumalogⓇ). A similar trend was observed when HumalogⓇ/glucagon was injected (306 mU×min/L vs 65 mU×min/L, SE = 125), although this difference did not reach statistical significance (P = 0.102) compared with the control groups. This series of proof-of-concept experiments in anesthetized pigs indicate that premixing nanogram doses of glucagon in fast-acting insulin lispro formulations may speed up the absorption of subcutaneously injected insulin."

Journal • Anesthesia

Role of Omnipod 5 Automated Insulin Infusion on Glucose Management in Patient with Anti-Insulin Antibodies (ENDO 2025) - "Previous management included metformin, Humalog 16 units before each meal, and Levemir 39 units at night. We believe this demonstrates successful management of the rare disorder of insulin autoimmune syndrome with the use of HumuLIN R U-200 insulin through Insulin Pump. Through multiple medication and treatment adjustments this patient's case shows an improvement over the course of treatment that can be used for future tests and trials."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Hypertension • Hypoglycemia • Immunology • Metabolic Disorders • Obstructive Sleep Apnea • Pain • Rare Diseases • Respiratory Diseases • Sleep Disorder • Type 2 Diabetes Mellitus

Post-surgical biliary pancreatitis and GAD positive diabetes: a rare case of Type 3c DM with Autoimmune features (ESPE-ESE 2025) - "Pain control due to opioid intolerance (hallucinations on morphine and nausea with oxycodone) required PCA fentanyl 20 mcg bolus, paracetamol, and diclofenac supplement...The patient was managed with basal-bolus insulin (Lantus 28 units nightly, Novorapid 8-14 units per meal ) and sliding scale correction for blood glucose 10 mmol/L. The patient was discharged with a management plan of Creon 250,000 units and Humalog 12-20 units with a meal. Tresiba long-acting double strength 84 units at night... This is an atypical instance of type 3c diabetes accompanied by post-surgical pancreatitis, biliary blockage, and a rapid onset of GAD-positive diabetes. Acute pancreatitis has been known to elevate GAD-antibody levels, which can result in insulin-dependent diabetes. The presented case is rare as GAD antibody levels are typically lower in autoimmune diabetes (less than 100 U/ML)."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Diabetes • Fatigue • Gastroenterology • Hepatology • Immunology • Insomnia • Metabolic Disorders • Pain • Pancreatitis • Pulmonary Disease • Respiratory Diseases • Sleep Disorder • Type 1 Diabetes Mellitus

Afrezza® INHALE-1 Study in Pediatrics (clinicaltrials.gov) - P3 | N=319 | Completed | Sponsor: Mannkind Corporation | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Mark D. DeBoer, MD, MSc., MCR

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

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