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MK-8245

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Sep 10, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

MK-8245 · 1 trial · 1 indication

Phase 1 1
NCT00972322Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)Type 2 Diabetes Mellitus
COMPLETED56 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)
Baseline and Day 28

The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

Number of Participants Who Experienced Serious or Non-serious Adverse Events
Up to Day 31

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Number of Participants Discontinuing Study Drug Due to an AE
Up to Day 28

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-8245 50 mgEXPERIMENTALMK-8245, 50 mg, twice daily for 28 days
PlaceboPLACEBO_COMPARATORPlacebo to MK-8245, 50 mg, twice daily

Interventions

NameTypeDescription
MK-8245DRUGMK-8245 50 mg twice daily for 28 days
Comparator: placeboDRUGmatching placebo to MK-8245 twice daily for 28 days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents * Subject is willing to follow a weight-maintaining diet and exercise program during the ...

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Frequently asked questions about MK-8245

What is MK-8245 used for?

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.

Who makes MK-8245?

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.

What phase is MK-8245 in?

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.

What clinical trials is MK-8245 in?

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.

Is MK-8245 the same as MK8245?

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.