A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK8245 50 mg b.i.d.; Drug: Placebo; Drug: MK8245 5 mg (twice a day) b.i.d.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846391

8245-005

2009_541

Details and patient eligibility

About

A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes Mellitus
• 18 to 65 years of age

Exclusion criteria

• History of Type 1 Diabetes or ketoacidosis
• Have been treated with lipid lowering medications 4 weeks before starting the study
• Have started on a weight loss program and not in the maintenance phase or have started weight loss medication within the last 12 weeks
• Have had surgery in the last 30 days
• History of active liver disease
• History of coronary heart disease or congestive heart failure
• Have had a stroke or transient ischemic neurological disorder in the past 6 months
• Are Human Immunodeficiency Virus (HIV) Positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 3 patient groups, including a placebo group

MK8245 5 mg b.i.d.

Experimental group

Description:

MK8245

Treatment:

Drug: MK8245 5 mg (twice a day) b.i.d.

MK8245 50 mg b.i.d.

Experimental group

Description:

MK8245

Treatment:

Drug: MK8245 50 mg b.i.d.

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo