BioChaperone glargine/lispro (insulin glargine/insulin lispro) / Adocia, Dongbao Enterprise Group - LARVOL DELTA

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Adocia | Recruiting ➔ Completed

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

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Adocia | Recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Oct 2022

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

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Adocia | Recruiting ➔ Completed

Trial completion

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Adocia

New P1 trial

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Adocia | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Adocia | Not yet recruiting ➔ Recruiting

Enrollment open

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Adocia | Not yet recruiting ➔ Recruiting

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

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Adocia

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Adocia

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus®) in Chinese patients with type 1 diabetes: a phase III, randomized, controlled trial. (PubMed, Diabetes Obes Metab) - "LY IGlar and IGlar had equivalent efficacy in glycemic control and similar safety profiles in Chinese patients with T1DM, when used in combination with mealtime insulin lispro."

Clinical • Journal • P3 data • Allergy • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

[VIRTUAL] Immunotherapy-Related Autoimmune Diabetes Mellitus and Exogenous Insulin Antibody Syndrome in a Patient With Metastatic Oral Squamous Cell Carcinoma (ENDO 2021) - "Case Description: A 63 years old Caucasian man with history of recurrent oral squamous cell cancer presented to emergency room with polyuria, polydipsia, nausea, and vomiting 3 months after initiation of immunotherapy (Durvalumab and cetuximab)...After a brief hospital stay, the patient was discharged home on insulin glargine and metformin...Switching insulin lispro to insulin aspart while he was on a different immunotherapy medication (Pembrolizumab) immediately reduced his average blood glucose and reduced his total daily insulin dosage by more than 50%... Evaluation for EIAS would be reasonable in insulin-treated diabetic patients who develop wide glucose excursions and unexplained fasting hypoglycemia while on immunotherapy. Unless otherwise noted, all poster abstracts presented at ENDO 2021 are embargoed until 11 AM Eastern on Saturday, March 20. For oral presentations, the abstracts are embargoed until the session begins."

Clinical • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Oncology • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] High Insulin Resistance in Pancreatic Adenocarcinoma (ENDO 2021) - "He was discharged on once daily insulin Glargine 25 units and mealtime insulin Lispro 10 units three times a day (TID) requiring 0.7 units/kg...He was discharged on Repaglinide 0.5mg TID with each meal and all his insulin was discontinued... The pathogenesis of pancreatic cancer associated diabetes has not been studied well. Basic science research found that adrenomedullin, an amionopeptide, is up-regulated in patients with pancreatic cancer and causes insulin resistance in β Cells. Cancer theories also found about metabolic reprogramming and metabolic cross talk happens between pancreatic cancer and peripheral tissue, inhibiting cellular glucose intake and inducing insulin resistance."

Atrial Fibrillation • Cardiovascular • Dermatology • Diabetes • Gastrointestinal Cancer • Genetic Disorders • Hepatology • Hypertension • Metabolic Disorders • Obesity • Oncology • Pain • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pruritus • Solid Tumor • ADM

[VIRTUAL] A Case of Diabetic Keto Acidosis From Alpelisib (ENDO 2021) - "She was bridged and subsequently transitioned to insulin glargine with insulin lispro sliding scale...Once hyperglycemia is detected, prompt initiation of oral hypoglycemic agent metformin (first line) or insulin therapy is recommended depending on the severity of the hyperglycemia...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Clinical • Breast Cancer • Cardiovascular • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Hypoglycemia • Metabolic Disorders • Oncology • Pain • Respiratory Diseases • Solid Tumor • HER-2 • PIK3CA

[VIRTUAL] Effect of stratification factors and baseline postprandial glucose on glycemic control after treatment with ultra rapid lispro or Humalog: subgroup analyzes of PRONTO-T1D (DDG 2021) - "In PRONTO-T1D, a phase 3, 26-week, treat-to-target study comparing URLi to Humalog in patients with type 1 diabetes (T1D) on a multiple daily injection regimen with insulin glargine or degludec, mealtime URLi was non-inferior to mealtime Humalog for change from baseline HbA1c and superior for PPG control with a similar safety profile to Humalog. Numerically, results suggest that basal insulin type, starting PPG, and starting HbA1c, but not prandial dosing plan, may influence the magnitude of the HbA1c improvement and / or hypoglycaemia risk reduction among patients treated with URLi compared to Humalog."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

SURPASS-6: A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (clinicaltrials.gov) - P3; N=1182; Recruiting; Sponsor: Eli Lilly and Company; Initiation date: Jan 2020 ➔ Oct 2020

Clinical • Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL) (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Mount Sinai Hospital, Canada; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

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

SURPASS-6: A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (clinicaltrials.gov) - P3; N=1182; Recruiting; Sponsor: Eli Lilly and Company; Initiation date: Oct 2020 ➔ Jan 2020

Clinical • Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes (clinicaltrials.gov) - P3; N=595; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus (clinicaltrials.gov) - P4; N=24; Completed; Sponsor: Emory University; Enrolling by invitation ➔ Completed; N=40 ➔ 24

Clinical • Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes (clinicaltrials.gov) - P3; N=350; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: May 2022 ➔ Feb 2022; Trial primary completion date: May 2022 ➔ Feb 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes (clinicaltrials.gov) - P=N/A; N=67; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed; N=50 ➔ 67

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

[VIRTUAL] Use of NPH insulin in a patient with uncontrolled type 2 diabetes on peritoneal dialysis (ASHP 2020) - "At the time of referral, the patient was using 20 units of insulin glargine nightly and 5 units of insulin lispro before meals. There is a paucity of evidence providing guidelines for the optimal management strategy in this patient population. However, the unique pharmacokinetic profile of NPH insulin may provide enhanced glucose control in this patient population over traditional long acting-rapid acting regimens as demonstrated in this case."

Clinical • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

[VIRTUAL] Assessment of hypoglycemic events associated with facility-administered insulin products at an academic medical center (ASHP 2020) - "Assessment focused on comparing insulin glargine prior to admission (PTA) dose and inpatient dose, sliding scale and fixed dosing of insulin lispro and insulin regular, and fixed dosing of insulin NPH. This review suggests insulin glargine was the most common offending agent associated with hypoglycemia at UConn Health. Collaborating with providers to consider a 20-30% dose reduction from long-acting insulin PTA dose may lessen hypoglycemic incidence. The electronic medical record may be utilized with alerts and suggested dose reduction values to facilitate this safety initiative."

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

[VIRTUAL] Polypharmacy, potentially inappropriate medications, and medications with anticholinergic burden in older African Americans with diabetes presenting to the emergency department (ASHP 2020) - "The most common medications taken included metformin (n = 75), insulin glargine (n = 52), and insulin lispro (n = 31). The prevalence of polypharmacy, potentially inappropriate medications, and anticholinergic burden remains high in older African Americans with diabetes that present to the emergency room. Providers should be aware of over-utilizing medication that is associated with causing harm to older adults. Many African Americans that do take more medications have better diabetes management, stronger beliefs that medications are necessary, and greater trust in physicians."

Diabetes • Metabolic Disorders

Insulin Binding to the Analytical Antibody Sandwich Pair OXI-005 and HUI-018 - Epitope Mapping and Binding Properties. (PubMed, Protein Sci) - "The epitopes for the mAbs on insulin were found well separated from each other as expected from luminiscent oxygen channeling immunoassay results for different insulins (HI, PI, bovine insulin, DesB30 HI, insulin glargine, insulin lispro). The affinities of the OXI-005 and HUI-018 Fabs for HI, PI and DesB30 HI were determined using surface plasmon resonance. The K s were found to be in the range of 1-4 nM for the HUI-018 Fab, while more different for the OXI-005 Fab (50 nM for HI, 20 nM for PI and 400 nM for DesB30 HI) supporting the importance of residue B30 for binding to OXI-005."

Journal