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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase IIa, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK8245 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00846391
• Other study ID #: 8245-005
• Secondary ID: 2009_541
• Status: Terminated
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: February 4, 2016
• Start date: December 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

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 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	No