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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: MK-8245
Drug: Comparator: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972322
8245-012
2009_655
MK-8245-012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups, including a placebo group

MK-8245 50 mg
Experimental group
Description:
MK-8245, 50 mg, twice daily for 28 days
Treatment:
Drug: MK-8245
Placebo
Placebo Comparator group
Description:
Placebo to MK-8245, 50 mg, twice daily
Treatment:
Drug: Comparator: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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