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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03095651 | Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002) | PHASE1 | COMPLETED | 33 | — | — | Apr 12, 2017 | Jan 30, 2018 | Apr 1, 2019 | 1 | United States |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Maximal glucose infusion rate required to maintain target glucose levels in a euglycemic clamp setting (GIRmax) at steady state (Day 12) following administration of study drug. In cases where the lower bound of the CI was negative, the lower confidence limit was truncated at zero. In these cases, the confidence intervals are 97.5% CIs.
| Arm | Type | Description |
|---|---|---|
| T1DM MK-5160 16 nmol/kg | EXPERIMENTAL | Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM MK-5160 32 nmol/kg | EXPERIMENTAL | Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM MK-5160 64 nmol/kg | EXPERIMENTAL | Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T1DM Glargine 0.4 U/kg | ACTIVE_COMPARATOR | Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 16 nmol/kg | EXPERIMENTAL | Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 32 nmol/kg | EXPERIMENTAL | Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM MK-5160 64 nmol/kg | EXPERIMENTAL | Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| T2DM Glargine 0.6 U/kg | ACTIVE_COMPARATOR | Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar. |
| Name | Type | Description |
|---|---|---|
| MK-5160 16 nmol/kg | BIOLOGICAL | MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days |
| MK-5160 32 nmol/kg | BIOLOGICAL | MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days |
| MK-5160 64 nmol/kg | BIOLOGICAL | MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days |
| Glargine 0.4 U/kg | BIOLOGICAL | Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days |
| Placebo to Glargine | BIOLOGICAL | Placebo to glargine, subcutaneous injection administered daily for 12 days |
| Placebo to MK-5160 | BIOLOGICAL | Placebo to MK-5160, subcutaneous injection administered daily for 12 days |
| Dextrose | DRUG | 20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours. |
| Glargine 0.6 U/kg | BIOLOGICAL | Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days |
Inclusion Criteria: * For Part 1 (T1DM): * Be male, or female of non-childbearing potential. A female of non-childbearing potential defined as a female who is postmenopausal without menses for at least 1 year and has a follicle stimulating hormone (FSH) value in the postmenopausal range upon pretri...