Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00792935 | A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017) | PHASE2 | COMPLETED | 143 | — | — | Jan 1, 2009 | Feb 1, 2010 | Dec 17, 2015 | - | — |
| NCT00824616 | A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018) | PHASE2 | COMPLETED | 68 | — | — | Jan 1, 2009 | May 1, 2010 | Jul 28, 2015 | - | — |
| NCT00511472 | An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006) | PHASE1 | COMPLETED | 70 | — | — | Jul 1, 2007 | Apr 1, 2008 | Jul 15, 2015 | - | — |
| NCT00511667 | A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005) | PHASE1 | COMPLETED | 70 | — | — | May 1, 2007 | Apr 1, 2008 | Aug 24, 2016 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| MK-0941 | EXPERIMENTAL | - |
| Glimepiride | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Participants receiving placebo tablets three times daily plus insulin injection once daily |
| 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. |
| 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 |
| Comparator: Placebo | DRUG | Placebo 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...