A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly... | NCT05462756

NCT05462756

ID	Type	Description	Link
I8H-MC-BDCV	Other Identifier	Eli Lilly and Company
2021-005878-25	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
500 U/mL - Insulin Efsitora	Experimental	Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed.	Drug: Insulin Efsitora Alfa Drug: Insulin Lispro (U100)
100 U/mL - Insulin Glargine	Active Comparator	Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.	Drug: Insulin Lispro (U100) Drug: Insulin Glargine (U100)

Name	Type	Description	Arm Group Labels	Other Names
Insulin Efsitora Alfa	Drug	Administered SC	500 U/mL - Insulin Efsitora

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.	Baseline, Week 26

Measure	Description	Time Frame
Change From Baseline in HbA1c [Superiority]	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.	Baseline, Week 26
Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
Are receiving ≥10 units of total basal insulin per day at screening.
Are receiving ≤2 units/kilogram/day of total daily insulin at screening
Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
- once daily U-100 or U-200 insulin degludec
- once daily U-100 or U-300 insulin glargine
- once or twice daily U-100 insulin detemir or
- once or twice daily human insulin Neutral Protamine Hagedorn
Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
- Insulin lispro-aabc
- Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
- Insulin aspart (U-100)
- Insulin glulisine (U-100), or
- Regular insulin (U-100)
Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
- dipeptidyl peptidase IV inhibitors
- sodium-glucose co-transporter-2 inhibitors
- biguanides (for example, metformin), or
- glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
- Have a body mass index ≤45 kilogram/square meter (kg/m²)

Exclusion Criteria:

Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
Are currently receiving any of the following insulin therapies anytime in the past 90 days:
- insulin mixtures
- insulin human, inhalation powder, or
- continuous subcutaneous insulin infusion therapy, or
- regular insulin U-500
Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
Have hypoglycemia unawareness in the opinion of the investigator
Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) Mon- Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CMR of Greater New Haven, LLC		Hamden	Connecticut	06517	United States
Tampa Bay Medical Research

PubMed Identifier	Type	Citation	Retractions
41591636	Derived	Miller E, Davidson MB, Bajaj HS, Rosenstock J, Philis-Tsimikis A, Bergenstal RM, Case M, Ilag L, Threlkeld R, Levasseur E, Gelsey F. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. Diabetes Ther. 2026 Mar;17(3):431-447. doi: 10.1007/s13300-025-01833-5. Epub 2026 Jan 27.
40562048

Label	URL
A Study of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	500 U/mL - Insulin Efsitora	Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC.
FG001	100 U/mL - Insulin Glargine

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 17, 2022	Feb 13, 2025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-1.01± 0.0463 OG001-1.00± 0.0463

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.					LS Mean Difference	-0.012			2-Sided	95	-0.140	0.116					Non-Inferiority	The sample size provided >99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.

Secondary

Change From Baseline in HbA1c [Superiority]

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

All participants who received at least one dose of study drug and had at least one post-baseline HbA1c data.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline, Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia

Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia [<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants

Secondary

Nocturnal Hypoglycemia Event Rate

The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose <54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Mean

Standard Error

Events per year

Baseline Up To Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Glucose

Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

milligrams per deciliter (mg/dL)

Baseline, Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Percentage of Time in Glucose Range

Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.

All participants who received at least one dose of the study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Percentage of time

Week 22 to Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Percentage of Time in Hypoglycemia Range

Percentage of Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Percentage of time

Week 22 to Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Percentage of Time in Hyperglycemia Range

Percentage of Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM.

All participants who received at least one dose of the study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Percentage of time

Week 22 to Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Glucose Variability Between Weeks 22 to 26

Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Coefficient of Variation

Week 22 to Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Basal Insulin Dose at Week 26

Average weekly basal Insulin Dose at Week 26 was reported.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Units per week of basal insulin

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Bolus Insulin Dose at Week 26

Average daily bolus Insulin Dose at Week 26 was reported.

All participants who received at least one dose of the study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Units per day of bolus insulin

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Total Insulin Dose at Week 26

Average total weekly insulin dose at Week 26 was reported.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Units per week of insulin

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Basal Insulin Dose to Total Insulin Dose Ratio at Week 26

Basal insulin dose to total insulin dose ratio at Week 26 was reported.

All participants who received at least one dose of the study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Ratio

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Hypoglycemia Event Rate

Hypoglycemia event rate was reported. Hypoglycemia with glucose <54 mg/dL (Level 2) or Severe Hypoglycemia (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia. Group mean was reported here.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Mean

Standard Error

Events per year

Baseline up to Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight

Change from baseline in body weight was reported.

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants	OG000

Secondary

Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)

The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics

All participants who received at least one dose of study drug and had evaluable data for this outcome.

Posted

Least Squares Mean

Standard Error

Score on a scale

Week 26

ID	Title	Description
OG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
OG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0011 events1 affected365 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected365 at risk EG0010 events0 affected365 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0012 events1 affected365 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected365 at risk EG0010 events0 affected365 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0011 events1 affected365 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Diabetic foot infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected365 at risk EG0011 events1 affected365 at risk
Soft tissue infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected365 at risk EG0015 events5 affected365 at risk
Spinal instability	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected193 at risk EG0010 events0 affected176 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Acute psychosis	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Postrenal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Aortic stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected365 at risk EG0011 events1 affected365 at risk
Hypertensive emergency	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected365 at risk EG0010 events0 affected365 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D049528	Insulin, Long-Acting

ID	Title	Description
BG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.
BG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	500 U/mL - Insulin Efsitora	Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.	1	365	25	365	35	365
EG001	100 U/mL - Insulin Glargine	Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.	1	365	24	365	40	365

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment		EG00017 events14 affected365 at risk EG00120 events19 affected365 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment		EG00025 events23 affected365 at risk EG00123 events21 affected365 at risk