Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK8245 · 1 trial · 1 indication
An LAE is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.
Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MK8245 |
| 2 | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| MK8245 | DRUG | MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken. |
| Comparator: Placebo | DRUG | MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken. |
Inclusion Criteria: * Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent * Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, t...
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MK-8245 is an investigational small molecule being developed for the treatment of Type 2 Diabetes and Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
MK-8245 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
MK-8245 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Clinical trials are ongoing to assess its safety, tolerability, and pharmacological effects in patients with Type 2 Diabetes.
MK-8245 has been studied in two completed Phase 1 clinical trials: NCT00790556 and NCT00972322. These trials evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in participants with Type 2 Diabetes.
MK-8245 and MK8245 refer to the same investigational drug. The naming convention may vary in different contexts, but both names denote the same compound being developed by Merck & Company, Inc. for Type 2 Diabetes.