Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04450394 | A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 278 | — | — | Jul 1, 2020 | Oct 8, 2021 | Nov 2, 2022 | 64 | United States, Argentina +3 |
| NCT03736785 | A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 399 | — | — | Nov 15, 2018 | Feb 18, 2020 | Mar 8, 2021 | 44 | United States, Mexico +1 |
| NCT06362265 | A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 15 | — | — | Oct 10, 2024 | Jan 2, 2026 | Mar 24, 2026 | 10 | United States |
| NCT04957914 | A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 54 | — | — | Jul 14, 2021 | Oct 17, 2022 | Nov 16, 2022 | 1 | Germany |
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, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) \[\<30, \>=30\]), visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
| Arm | Type | Description |
|---|---|---|
| LY3209590 Algorithm 1 (Paper) | EXPERIMENTAL | 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 baseline median fasting glucose and body weight 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) | EXPERIMENTAL | 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 baseline median fasting glucose and body weight 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. As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry. |
| Insulin Degludec | ACTIVE_COMPARATOR | 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 of 10 units, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL. |
| LY3209590 Algorithm 1 | EXPERIMENTAL | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL). |
| LY3209590 Algorithm 2 | EXPERIMENTAL | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL. |
| LY3209590 | EXPERIMENTAL | LY3209590 administered subcutaneously (SC). |
| Insulin Glargine (Period 1) | ACTIVE_COMPARATOR | Insulin glargine administered subcutaneously (SC). |
| LY3209590 (Period 2) | EXPERIMENTAL | LY3209590 administered SC. |
| Name | Type | Description |
|---|---|---|
| LY3209590 | DRUG | Administered SC |
| Insulin Degludec | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC |
Inclusion Criteria: * Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inh...