A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK-0431 to Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy - MK-0431 Metformin Add-on Study

Phase 1

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

• Registration Number: EUCTR2004-000312-93-DK
• Lead Sponsor: Merck Sharp & Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-12
• Study Completion: 2007-02-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

a.Patient has type 2 diabetes mellitus (T2DM).
b.Patient is greater than or equal to18 and less than or equal to78 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 greater than or equal to 7% and less than or equal to10% 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.Serum creatinine greater than or equal to1.4 mg/dL (123.8 µmol/L) in men and greater than or equal to 1.3 mg/dL (114.9 µmol/L) in women or estimated creatinine clearance (using Cockcroft-Gault formula) <60 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)
•Stroke or transient ischemic neurological disorder
•Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
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 any other reason to expect that the patient 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