Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-5160 16 nmol/kg · 1 trial · 2 indications
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...
MK-5160 is an investigational monoclonal antibody being studied for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MK-5160 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.
MK-5160 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.
MK-5160 has one completed clinical trial, NCT03095651, a multiple ascending dose study in participants with Type 1 and Type 2 Diabetes Mellitus. The trial enrolled 33 participants in the United States.
MK-5160 is not FDA approved. It is an investigational monoclonal antibody in Phase 1 clinical development for Type 1 Diabetes Mellitus, and its safety and efficacy have not been established.