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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03751657 | A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes. | PHASE2 | COMPLETED | 247 | — | — | Nov 29, 2018 | Jan 17, 2020 | Apr 2, 2021 | 49 | United States, Canada +5 |
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i.
Change in HbA1c from baseline (week 0) to week 26 is presented. The endpoint was evaluated based on the data from on-treatment without ancillary treatment period, starting at the date of first dose of trial product until the follow-up visit, or the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin, or initiation of any diabetes treatment other than trial products and metformin +/- DPP4i, or increase of the dose of metformin or DPP4i.
| Arm | Type | Description |
|---|---|---|
| Insulin 287 | EXPERIMENTAL | Participants will receive once weekly insulin 287 and once daily placebo in combination with metformin with or without dipeptidyl peptidase-4 inhibitors (DPP4i) during 26 weeks of treatment period. |
| Insulin glargine | ACTIVE_COMPARATOR | Participants will receive once daily insulin glargine and once weekly placebo in combination with metformin with or without DPP4i during 26 weeks of treatment period. |
| Name | Type | Description |
|---|---|---|
| Insulin icodec | DRUG | Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL) |
| Placebo (insulin 287) | DRUG | Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287. |
| Metformin | DRUG | Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose. |
| Dipeptidyl peptidase-4 inhibitors | DRUG | Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose. |
| Insulin glargine | DRUG | Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL). |
| Placebo (insulin glargine) | DRUG | Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine. |
Inclusion Criteria: * Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening * HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central labo...