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

Phase 2TerminatedNCT00846391

Merck Sharp & Dohme LLC14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

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

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.

MK8245 50 mg b.i.d.DRUG

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.

PlaceboDRUG

All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4

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 to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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