Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1293 · 3 trials · 2 indications
A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.
Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.
Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.
This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.
Duration of Action (DOA) is defined as the length of time from dosing to End of Action. End of Action is defined as the time point at which plasma glucose has been above 150 mg/dL for 30 minutes and no glucose has been infused for 30 minutes. Median and max below are reported for the length of clamp duration (i.e. 30 hours).
The area under the glucose infusion rate curve from hours 0 to 24 after injection (AUC\[GIR{0-24}\]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.
The area under the glucose infusion rate curve from hours 0 to 12 after injection (AUC\[GIR{0-12}\]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.
The area under the glucose infusion rate curve from hours 12 to 24 after injection (AUC\[GIR{12-24}\]) for participants who received either MK-1293 or Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.
Maximum glucose infusion rate (GIR\[max\]) based on smoothed data for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.
M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Analysis was performed on log scale with results back transformed to the original scale
M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Analysis was performed on log scale with results back transformed to original scale.
| Arm | Type | Description |
|---|---|---|
| MK-1293 | EXPERIMENTAL | MK-1293 administered subcutaneously once daily in the evening. |
| Lantus™ | ACTIVE_COMPARATOR | Lantus™ administered subcutaneously once daily in the evening. |
| Lantus | ACTIVE_COMPARATOR | Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™ | EXPERIMENTAL | MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period |
| EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293 | EXPERIMENTAL | MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period |
| Name | Type | Description |
|---|---|---|
| MK-1293 | DRUG | MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
| Lantus™ | DRUG | Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
| Prandial insulin | DRUG | Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control. |
| EU-Lantus™ | DRUG | EU-Lantus™ 0.4 units/kg administered subcutaneously |
| Novolog™ | DRUG | Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements |
Inclusion Criteria: * Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD) * hemoglobin A1C of ≤11.0% and requires insulin for glycemic control * Body mass index (BMI) \<45 kg/m\^2 Exclusion ...
MK-1293 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is being studied as a potential therapy to manage blood sugar levels in patients with these conditions.
MK-1293 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of MK-1293 in patients with diabetes.
MK-1293 has completed Phase 3 clinical trials for both Type 1 and Type 2 Diabetes Mellitus. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development, with completed trials providing data on its safety and efficacy.
MK-1293 has been studied in three completed clinical trials. NCT02059161 was a Phase 3 trial in Type 1 Diabetes Mellitus with 508 participants. NCT02059174 was a Phase 1 trial in Type 1 Diabetes with 76 participants. NCT02059187 was a Phase 3 trial in Type 2 Diabetes with 531 participants.
MK-1293 is being compared to Lantus in clinical trials, but it is not the same drug. Lantus is a brand-name basal insulin, while MK-1293 is a separate investigational compound. The trials are designed to evaluate whether MK-1293 is as safe and effective as Lantus in treating diabetes.