Trial Outcomes & Findings for A Study of LY3209590 in Participants With Type 1 Diabetes (NCT NCT04450407)

Last Updated: 2022-10-27

Results Overview

HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

266 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2022-10-27

Participant Flow

The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the "LY3209590 Algorithm 2 (Digital)" arm during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.

Participant milestones

Participant milestones
Measure	LY3209590 Algorithm 1 (Paper) Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL).	LY3209590 Algorithm 2 (Digital) Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Overall Study STARTED	124	16	126
Overall Study Received at Least One Dose of Study Drug	123	16	126
Overall Study COMPLETED	107	15	118
Overall Study NOT COMPLETED	17	1	8

Reasons for withdrawal

Reasons for withdrawal
Measure	LY3209590 Algorithm 1 (Paper) Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL).	LY3209590 Algorithm 2 (Digital) Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Overall Study Withdrawal by Subject	10	1	4
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Physician Decision	0	0	1
Overall Study Pregnancy	1	0	0
Overall Study Protocol Violation	2	0	0
Overall Study Investigational site terminated by sponsor	3	0	2

Baseline Characteristics

All randomized participants with HbA1c data at baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3209590 Algorithm 1 (Paper) n=124 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	LY3209590 Algorithm 2 (Digital) n=16 Participants Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=126 Participants Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.	Total n=266 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 14.8 • n=124 Participants	53.4 years STANDARD_DEVIATION 16.3 • n=16 Participants	47.4 years STANDARD_DEVIATION 13.7 • n=126 Participants	46.4 years STANDARD_DEVIATION 14.5 • n=266 Participants
Sex: Female, Male Female	50 Participants n=124 Participants	4 Participants n=16 Participants	48 Participants n=126 Participants	102 Participants n=266 Participants
Sex: Female, Male Male	74 Participants n=124 Participants	12 Participants n=16 Participants	78 Participants n=126 Participants	164 Participants n=266 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=124 Participants	5 Participants n=16 Participants	10 Participants n=126 Participants	38 Participants n=266 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=124 Participants	11 Participants n=16 Participants	116 Participants n=126 Participants	227 Participants n=266 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=124 Participants	0 Participants n=16 Participants	0 Participants n=126 Participants	1 Participants n=266 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=124 Participants	0 Participants n=16 Participants	0 Participants n=126 Participants	0 Participants n=266 Participants
Race (NIH/OMB) Asian	2 Participants n=124 Participants	0 Participants n=16 Participants	2 Participants n=126 Participants	4 Participants n=266 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=124 Participants	0 Participants n=16 Participants	0 Participants n=126 Participants	0 Participants n=266 Participants
Race (NIH/OMB) Black or African American	2 Participants n=124 Participants	2 Participants n=16 Participants	4 Participants n=126 Participants	8 Participants n=266 Participants
Race (NIH/OMB) White	119 Participants n=124 Participants	14 Participants n=16 Participants	120 Participants n=126 Participants	253 Participants n=266 Participants
Race (NIH/OMB) More than one race	1 Participants n=124 Participants	0 Participants n=16 Participants	0 Participants n=126 Participants	1 Participants n=266 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=124 Participants	0 Participants n=16 Participants	0 Participants n=126 Participants	0 Participants n=266 Participants
Region of Enrollment Puerto Rico	7 Participants n=124 Participants	1 Participants n=16 Participants	3 Participants n=126 Participants	11 Participants n=266 Participants
Region of Enrollment Austria	6 Participants n=124 Participants	0 Participants n=16 Participants	6 Participants n=126 Participants	12 Participants n=266 Participants
Region of Enrollment United States	80 Participants n=124 Participants	15 Participants n=16 Participants	84 Participants n=126 Participants	179 Participants n=266 Participants
Region of Enrollment Germany	16 Participants n=124 Participants	0 Participants n=16 Participants	18 Participants n=126 Participants	34 Participants n=266 Participants
Region of Enrollment Spain	15 Participants n=124 Participants	0 Participants n=16 Participants	15 Participants n=126 Participants	30 Participants n=266 Participants
Haemoglobin A1c (HbA1c)	7.52 Percentage of HbA1c STANDARD_DEVIATION 0.85 • n=124 Participants • All randomized participants with HbA1c data at baseline.	7.64 Percentage of HbA1c STANDARD_DEVIATION 0.70 • n=16 Participants • All randomized participants with HbA1c data at baseline.	7.45 Percentage of HbA1c STANDARD_DEVIATION 0.87 • n=125 Participants • All randomized participants with HbA1c data at baseline.	7.49 Percentage of HbA1c STANDARD_DEVIATION 0.85 • n=265 Participants • All randomized participants with HbA1c data at baseline.

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline HbA1c data prior to treatment discontinuation.

Outcome measures

Outcome measures
Measure	LY3209590 Algorithm 1 (Paper) n=118 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=123 Participants Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Change From Baseline in Hemoglobin A1c (HbA1c)	0.04 Percentage of HbA1c Standard Error 0.068	-0.13 Percentage of HbA1c Standard Error 0.065

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline fasting serum glucose data prior to treatment discontinuation.

LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate.

Outcome measures

Outcome measures
Measure	LY3209590 Algorithm 1 (Paper) n=118 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=124 Participants Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Change From Baseline in Fasting Serum Glucose	-5.9 milligrams per deciliter (mg/dL) Standard Error 5.65	-16.7 milligrams per deciliter (mg/dL) Standard Error 5.21

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline bolus insulin dose data prior to treatment discontinuation.

Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate.

Outcome measures

Outcome measures
Measure	LY3209590 Algorithm 1 (Paper) n=79 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=81 Participants Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Change From Baseline in Bolus Insulin Dose	0.04 Units per kilogram per day (U/kg/day) Standard Error 0.019	0.05 Units per kilogram per day (U/kg/day) Standard Error 0.018

SECONDARY outcome

Timeframe: Baseline through Week 26

Population: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug.

Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose \<54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants.

Outcome measures

Outcome measures
Measure	LY3209590 Algorithm 1 (Paper) n=123 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=126 Participants Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Rate of Documented Hypoglycemia	20.7 Events per participant per year Standard Error 2.27	18.4 Events per participant per year Standard Error 2.00

SECONDARY outcome

Timeframe: Week 26

Population: All participants randomized to LY3209590 Algorithm 1 (Paper), received at least one dose of study drug and had evaluable PK data at Week 26.

AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and the estimated clearance value.

Outcome measures

Outcome measures
Measure	LY3209590 Algorithm 1 (Paper) n=99 Participants Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590	3520 Nanomolehour per Liter (nmolhr/L) Geometric Coefficient of Variation 53	—

Adverse Events

LY3209590 Algorithm 1 (Paper)

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

LY3209590 Algorithm 2 (Digital)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Insulin Degludec

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LY3209590 Algorithm 1 (Paper) n=124 participants at risk Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	LY3209590 Algorithm 2 (Digital) n=16 participants at risk Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=126 participants at risk Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Cardiac disorders Acute myocardial infarction	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Maternal exposure during pregnancy	2.0% 1/50 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/48 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	LY3209590 Algorithm 1 (Paper) n=124 participants at risk Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	LY3209590 Algorithm 2 (Digital) n=16 participants at risk Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.	Insulin Degludec n=126 participants at risk Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
General disorders Injection site bruising	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	1.6% 2/124 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 2/126 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	2.4% 3/124 • Number of events 4 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Onychomycosis	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sinusitis	1.6% 2/124 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.00% 0/124 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.79% 1/126 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Sars-cov-2 test positive	1.6% 2/124 • Number of events 2 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	8.1% 10/124 • Number of events 14 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/16 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.0% 5/126 • Number of events 5 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.81% 1/124 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/126 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	3.2% 4/124 • Number of events 4 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 1/16 • Number of events 1 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.4% 3/126 • Number of events 3 • Baseline to Follow-up (up to 31 weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800- 545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60