A Multicenter, Randomized, Double-Blind Study of MK-0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - MK-0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 7.0Level: LLTClassification code 10045242

• Registration Number: EUCTR2004-000867-92-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

a.Patient has type 2 diabetes mellitus.
b.Patient is =18 to =75 years of age.
c.Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
d.Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period.
e.Patient is a male, or a female who is highly unlikely to conceive.
f. HbA1C =7% and =10% measured at or within 2 weeks prior to Visit 3.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a.Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
b.Patient has an ALT or AST >2.0-fold the upper limit of normal (ULN).
c.Patient’s renal function is reflected below as indicated by a yes” answer to one of the following:
1)Patient is a male =65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L).
2)Patient is a female =65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
3)Patient is a male >65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
4)Patient is a female >65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L).
5)Creatinine clearance is <50 mL/min.
d.Patient has any of the following disorders within the past 6 months:
•Acute coronary syndrome (e.g., MI or unstable angina).
•Coronary artery intervention (e.g., CABG or PTCA).
•Worsening congestive heart failure (e.g., worsening symptoms or increase in pharmacologic therapy).
•Stroke or transient ischemic neurological disorder.
e.Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
f.Patient has a BMI <20 kg/m2 or >43 kg/m2.
g.Patient has a positive urine pregnancy test.
h.Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
i.Patient has poor mental function or there is any other reason to expect that they may have difficulty in complying with the requirements of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified