None listed
Conditions
Interventions
Group 1 Type of group
Sitagliptin 100 mg tablet orally once daily for 26 weeks.
Group name:Group 2 Type of group
Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: • The patient has T2DM and is > 18 and 8 weeks before Visit 1) of dual AHA therapy: a PPARy agonist (rosiglitazone> 4 mg daily or pioglitazone> 30 mg daily) combined with metformin> 1500 mg per day and has an A1C in Visit 1 / Selection Visit> 7.5% and 8.0% on Visit 1 / Selection Visit, but is not at the dose specified in the protocol in one or both drugs specified by the protocol. • The patient is currently with dual therapy with AHA: metformin (> 1500 mg per day) and a sulfonylurea agent and has an A1C> 7.5% and 8% on Visit 1 / Selection Visit. • The patient has A1C> 7.5% and 30 mg per day) combined with metformin (> 1500 mg per day) for> 10 weeks before Visit 4 . • The patient has ^ 85% compliance with placebo treatment during the simple blind transition, as measured by the tablet count performed at the site.
Exclusion criteria
Exclusion criteria: • The patient has a history of type 1 diabetes mellitus, a history of ketoacidosis, or the patient is evaluated by the researcher for a possibility of type 1 diabetes and is confirmed with a C-peptide value 14 consecutive days, or repeated cycles, or will probably need this treatment. • The patient has a medical history of active liver disease (other than non-alcoholic liver steatosis), including chronic active hepatitis B or C (evaluated by medical history), primary biliary cirrhosis or symptomatic gallbladder disease. • The patient is HIV positive (based on medical history evaluation). • The patient has congestive heart failure Class I, II, III, or IV according to the New York Heart Association (NYHA), or a history of congestive heart failure, or the patient has new or worsening signs or symptoms of coronary heart disease within the last 3 months. • The patient has severe active peripheral vascular disease (such as that manifested with claudication with minimal activity, ischemic ulcer difficult to heal, or disease that will probably need an intervention such as bypass or angioplasty). • The patient has a history of malignant diseases or clinically important hematological disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. Measure:Change From Baseline in Hemoglobin A1c (A1C) at Week 26 Timepoints:Baseline and Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline reflects the Week 26 value minus the baseline value. Measure:Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26 Timepoints:Baseline and Week 26 ; Outcome name:Change from baseline reflects the Week 26 value minus the baseline value. Measure:Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Timepoints:Baseline and Week 26 | — |
Countries
Canada, Costa Rica, Croatia, Italy, New Zealand, Peru, Serbia, South Africa, Spain, Thailand, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed