Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-0941 · 8 trials · 4 indications
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL \[3.9 mmol/L\] with or without symptoms or symptomatic hypoglycemia.
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Only treatment-emergent adverse events were examined for this outcome measure.
An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.
Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24
Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
| Arm | Type | Description |
|---|---|---|
| MK-0941 | EXPERIMENTAL | - |
| Glimepiride | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Participants receiving placebo tablets three times daily plus insulin injection once daily |
| Treatment Sequence 1 | EXPERIMENTAL | Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg |
| Treatment Sequence 2 | EXPERIMENTAL | Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo |
| Treatment Sequence 3 | EXPERIMENTAL | Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg |
| Treatment Sequence 4 | EXPERIMENTAL | Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg |
| 1 | EXPERIMENTAL | MK-0941 |
| 2 | PLACEBO_COMPARATOR | Placebo Comparator |
| Placebo/MK-0941 20mg | EXPERIMENTAL | Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 5mg/Placebo | EXPERIMENTAL | Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 5mg/MK-0941 20mg | EXPERIMENTAL | Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| Placebo/MK-0941 40mg | EXPERIMENTAL | Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 10mg/Placebo | EXPERIMENTAL | Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK-0941 10mg/MK-0941 40mg | EXPERIMENTAL | Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. |
| MK0941 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MK-0941 | DRUG | MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks. |
| Glimepiride | DRUG | Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks. |
| Metformin | DRUG | The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], the participant should remain on the same metformin dose throughout the study. |
| Placebo | DRUG | Placebo tablets, taken 3 times daily. |
| Insulin | DRUG | Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily. |
| Comparator: Placebo | DRUG | a single oral placebo will be administered in the designated period (Periods 1-5) |
| LANTUS insulin | DRUG | LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin |
| MK0941 | DRUG | MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day |
Inclusion Criteria: * Patient has type 2 diabetes mellitus * Between the ages of 18 and 70 Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or ketoacidosis. * Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication. * Pati...
MK-0941 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for the treatment of type 2 diabetes mellitus. It was studied in clinical trials as a potential oral therapy for adults with type 2 diabetes, including patients with inadequate glycemic control on insulin. It is not an approved medicine.
MK-0941 was being studied for type 2 diabetes mellitus, including non-insulin-dependent diabetes. Trials enrolled adults with type 2 diabetes, and one Phase 2 study tested it in adults with inadequate glycemic control on insulin. It is an investigational agent and is not approved for treating diabetes or any other condition.
MK-0941 targets glucokinase (GCK) and acts as a glucokinase activator. Glucokinase is an enzyme involved in glucose metabolism, and activating it is the intended mechanism for lowering blood glucose in type 2 diabetes. The drug is a small molecule developed by Merck.
MK-0941 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical trial program for the compound, including the Phase 1 pharmacokinetic studies and the Phase 2 study in adults with type 2 diabetes mellitus.
MK-0941 is in Phase 1 development overall, though its clinical program included a Phase 2 study. It is investigational and has not been approved by the FDA. Five trials have been completed, with no active trials, and total enrollment across the program was 395 participants.
Completed MK-0941 trials include NCT01106287, a Phase 1 single-dose study in type 2 diabetics; NCT00912002, a Phase 1 absorption, metabolism, excretion and mass balance study; NCT00873821, a Phase 1 multiple-dose pharmacokinetic study; and NCT00824616, a Phase 2 study in adults with type 2 diabetes and inadequate glycemic control on insulin.
Yes, MK-0941 and MK0941 refer to the same investigational compound. MK-0941 is the hyphenated form of the name, while MK0941 is the unhyphenated form used in some references. Both names identify the glucokinase activator developed by Merck & Company, Inc. for type 2 diabetes.