A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety of MK-0431Monotherapy in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control - MK-0431 Monotherapy Study in Patients With Type 2 DM and Chronic Renal Insufficiency
- Conditions
- Type 2 Diabetes MellitusChronic Renal Insufficiency [MedDRA classification code: 10050441]MedDRA version: 7.0Level: LLTClassification code 10045242
- Registration Number
- EUCTR2004-002160-22-HU
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
a.Patient has type 2 diabetes mellitus (T2DM).
b.Patient has moderate, severe, or end-stage renal insufficiency as indicated by a ‘yes’ answer to one or more of the following :
1)Creatinine clearance =30 to < 50 mL/min
2)Creatinine clearance < 30 mL/min
3)Patient receiving dialysis
c.Patient is =18 years of age.
d.Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
e.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.
f.Patient is a male, or a female who is highly unlikely to conceive.
g.HbA1c =6.5% 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
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 has acute or rapidly progressive renal disease, or a history of renal transplant.
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 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
- Primary Outcome Measures
Name Time Method Main Objective: In patients with type 2 diabetes mellitus and chronic renal insufficiency with inadequate glycemic control<br><br>Primary: To assess the safety and tolerability of MK-0431 after 12 weeks.<br>;Secondary Objective: In patients with type 2 diabetes mellitus and chronic renal insufficiency with inadequate glycemic control<br><br>To assess the safety and tolerability of MK-0431 over 54 weeks.;Primary end point(s): N/A
- Secondary Outcome Measures
Name Time Method