Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972322
• Other study ID #: 8245-012
• Secondary ID: MK-8245-0122009_
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2009
• Est. completion date: January 26, 2010

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 26, 2010
• Est. primary completion date: January 12, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 study

• Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

• Subject has a history of stroke, chronic seizures, or major neurological disorder

• Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening

• Subject has a history of type 1 diabetes

• Subject has used contact lenses within the last 6 months

• Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin

• Subject has more than 3 alcoholic beverages per day

• Subject has more than 6 servings of caffeine a day

• Subject has participated in a previous MK8245 study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK-8245
MK-8245 50 mg twice daily for 28 days
• Comparator: placebo
matching placebo to MK-8245 twice daily for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)	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.	Baseline and Day 28
Primary	Number of Participants Who Experienced Serious or Non-serious Adverse Events	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.	Up to Day 31
Primary	Number of Participants Discontinuing Study Drug Due to an AE	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.	Up to Day 28