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

NCT00846391 | Terminated Phase 2 Results

• 2 other identifiers: 8245-0052009_541
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 4

Study Arms (3)

MK8245 5 mg b.i.d.

EXPERIMENTAL

MK8245

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

MK8245 50 mg b.i.d.

EXPERIMENTAL

MK8245

Drug: MK8245 50 mg b.i.d.

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

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.

Also known as: MK8245

MK8245 5 mg b.i.d.

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.

Also known as: MK8245

MK8245 50 mg b.i.d.

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(5-(3-(4-(2-bromo-5-fluorophenoxy)piperidin-1-yl)isoxazol-5-yl)-2H-tetrazol-2-yl)acetic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This study was terminated due to the continuing inability to recruit patients. No efficacy analysis was performed because of insufficient sample size for meaningful analysis due to early study termination and insufficient sample size.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 5, 2016
• Results First Posted: September 21, 2010

Record last verified: 2016-02