Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1092, 4.0 nmol/kg · 1 trial · 2 indications
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...
MK-1092 is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated for its safety and tolerability in clinical trials.
MK-1092 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.
MK-1092 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in early-stage trials to assess its safety, tolerability, and pharmacokinetics in healthy participants and patients with diabetes.
MK-1092 has one completed clinical trial, NCT03170544, titled "Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)." This Phase 1 study enrolled 69 participants in the United States and was randomized, double-blind, and active-controlled.
MK-1092 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is being developed specifically for Type 1 Diabetes Mellitus and is not known to be marketed under any other name.