Type 2 Diabetes Mellitus Chronic Renal Insufficiency [MedDRA classification code: 10050441] MedDRA version: 7.0 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: MK-0431 25-mg Tablet
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0431
Other descriptive name: L-000224715
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with type 2 diabetes mellitus and chronic renal insufficiency with inadequate glycemic control Primary: To assess the safety and tolerability of MK-0431 after 12 weeks. ;Secondary Objective: In patients with type 2 diabetes mellitus and chronic renal insufficiency with inadequate glycemic control To assess the safety and tolerability of MK-0431 over 54 weeks.;Primary end point(s): N/A | — |
Countries
Hungary, Spain
Outcome results
None listed