| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03170544 | Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001) | PHASE1 | COMPLETED | 69 | — | — | Aug 16, 2017 | Nov 8, 2018 | Nov 15, 2019 | 1 | United States |
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.
| Arm | Type | Description |
|---|---|---|
| Part 1, MK-1092, 4.0 nmol/kg | EXPERIMENTAL | MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 1, MK-1092, 8.0 nmol/kg | EXPERIMENTAL | MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 1, MK-1092, 16 nmol/kg | EXPERIMENTAL | MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 1, MK-1092, 32 nmol/kg | EXPERIMENTAL | MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 1, MK-1092, 64 nmol/kg | EXPERIMENTAL | MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 1, Glargine, 3.0 nmol/kg | ACTIVE_COMPARATOR | Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants |
| Part 2, MK-1092, 8.0 nmol/kg + lispro, 1.2 nmol/kg | EXPERIMENTAL | MK-1092, 8.0 nmol/kg dose selection based on Part 1 + lispro (Humalog®), 1.2 nmol/kg, as a single dose, in healthy participants |
| Part 3, MK-1092, 8.0 nmol/kg | EXPERIMENTAL | MK-1092, (8.0 nmol/kg based on Part 1), SC, in participants with T1DM. |
| Part 3, MK-1092, 32 nmol/kg | EXPERIMENTAL | MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM |
| Part 3, Glargine, 3.0 nmol/kg | ACTIVE_COMPARATOR | Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T1DM |
| Part 4, MK-1092, 32 nmol/kg | EXPERIMENTAL | MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T2DM |
| Part 4, MK-1092, 16 nmol/kg | EXPERIMENTAL | MK-1092, 16 nmol/kg, SC, as a single dose, in participants with T2DM |
| Part 4, MK-1092, 64 nmol/kg | EXPERIMENTAL | MK-1092, 64 nmol/kg, SC, as a single dose, in participants with T2DM |
| Part 4, Glargine, 3.0 nmol/kg | ACTIVE_COMPARATOR | Glargine, 3.0 nmol/kg, SC, as a single dose, in participants with T2DM |
| Name | Type | Description |
|---|---|---|
| MK-1092, 4.0 nmol/kg | DRUG | MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants |
| MK-1092, 8.0 nmol/kg | DRUG | MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants |
| MK-1092, 16 nmol/kg | DRUG | MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants |
| MK-1092, 32 nmol/kg | DRUG | MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants |
| MK-1092, 64 nmol/kg | DRUG | MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants |
| Glargine 3.0 nmol/kg | DRUG | Glargine 3.0 nmol/kg, SC, as a single dose |
| Lispro 1.2 nmol/kg | DRUG | Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting \~12 hours after MK-1092 administration. |
| Placebo to glargine | DRUG | Placebo to glargine, SC, as a single dose |
| Placebo to MK-1092 | DRUG | Placebo to MK-1092, SC, as a single dose |
| Dextrose | OTHER | 20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels. |
| Insulin | BIOLOGICAL | Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing. |
Subject Inclusion Criteria All participants * Be a healthy male, or healthy female participant (excluding diabetes mellitus in Part 3 participants) of non-child bearing potential. A female non-child bearing potential is one who is postmenopausal without menses for at least 1 year or whose status i...