Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK0893 · 4 trials · 2 indications
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within \~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes
| Arm | Type | Description |
|---|---|---|
| MK-0893 + Sitagliptin | EXPERIMENTAL | - |
| MK-0893 + Metformin | EXPERIMENTAL | - |
| Sitagliptin + Metformin | ACTIVE_COMPARATOR | - |
| MK-0893 (40 mg) | EXPERIMENTAL | MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. |
| MK-0893 (120 mg) | EXPERIMENTAL | MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893 |
| Metformin (2000 mg) | ACTIVE_COMPARATOR | Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets matching the MK-0893 and placebo tablets matching metformin. |
| Propanolol + Placebo > Propanolol + MK0893 | EXPERIMENTAL | Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8). |
| Propanolol + MK0893 > Propanolol + Placebo | PLACEBO_COMPARATOR | Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8). |
| MK-0893 40 mg→MK-0893 200 mg→placebo | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| MK-0893 200 mg→placebo→MK-0893 10 mg | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| Placebo→MK-0893 10 mg→MK-0893 40 mg | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| Placebo→MK-0893 1000 mg→MK-0893 200 mg | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| MK-0893 200 mg→placebo→MK-0893 1000 mg | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| MK-0893 1000 mg→MK-0893 200 mg→placebo | EXPERIMENTAL | In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs. |
| Name | Type | Description |
|---|---|---|
| MK-0893 | DRUG | Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks). |
| Sitagliptin | DRUG | Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). |
| Metformin | DRUG | Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks). |
| Placebo for MK-0893 | DRUG | Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period. |
| Placebo for Sitagliptin | DRUG | Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks). |
| Placebo for Metformin | DRUG | Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks). |
| Placebo | DRUG | Placebo tablets matching MK-0893 |
| MK0893 | DRUG | Single dose of MK0893 1000 mg (ten 100 mg tablets) |
| MK0893-matched Placebo | DRUG | Single dose of placebo to MK0893 (ten tablets) |
| Propranolol Hydrochloride (HCL) | DRUG | Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks. |
| MK-0893 10 mg | DRUG | MK-0893 10 mg administered orally in 240 mL of water |
| MK-0893 40 mg | DRUG | MK-0893 40 mg administered orally in 240 mL of water |
| MK-0893 200 mg | DRUG | MK-0893 200 mg administered orally in 240 mL of water |
| MK-0893 1000 mg | DRUG | MK-0893 1000 mg administered orally in 240 mL of water |
| Sandostatine® | BIOLOGICAL | Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min. |
| Insulin | BIOLOGICAL | At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min. |
| Glucagon | BIOLOGICAL | At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min. |
Inclusion Criteria: * Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: * Participants have a history of Type 1 Diabetes Mellitus * Par...
MK0893 is an investigational oral small molecule developed for the treatment of Type 2 Diabetes Mellitus. It was studied for its glucose-lowering effects, including a Phase 2 trial evaluating safety, tolerability, and efficacy in participants with Type 2 Diabetes Mellitus. It is not approved for any indication.
MK0893 targets the glucagon receptor, also known as GCGR. It acts as a GCGR antagonist, meaning it blocks the receptor's activity. This mechanism was explored for lowering blood glucose in Type 2 Diabetes Mellitus.
MK0893 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the clinical trials for the drug.
MK0893 is in Phase 2 clinical development for Type 2 Diabetes Mellitus. It has completed four trials, including two Phase 2 studies and two Phase 1 studies. It is investigational and has not been approved by the FDA.
MK0893 has been studied in four completed clinical trials. These include NCT02012166, a Phase 1 trial in healthy male participants; NCT02004886, a Phase 2 trial assessing safety and glucose-lowering efficacy; NCT00902161, a Phase 1 single-dose crossover study; and NCT00631488, a Phase 2 trial testing MK0893 in combination with other diabetes drugs.
Yes, MK0893 is the same as MK-0893. The alternative name MK-0893 10 mg refers to a specific dose strength used in trials. Both names refer to the same investigational drug for Type 2 Diabetes Mellitus.