None listed
Conditions
Interventions
Group 1 Type of group
vildagliptin MR 12.5 mg bid + metformin in period 1
vildagliptin MR 12.5 mg bid + metformin in the intermediate
sitagliptin 50 mg bid + metformin in period 1
sitagliptin 50 mg bid + metformin in intermediate period
sitagliptin 50 mg bid + metformin in period 2
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: • Man, non-fertile women or women with the potential to become pregnant who use a medically approved method of birth control. • Age in the range of 18 - 78 years inclusive in Visit 1. • Patients with DMT2 treated with metformin for at least 3 months and with a stable dose of at least 1,500 mg daily for a minimum of 4 weeks before Visit 1. • Agreement to maintain the same dose of metformin throughout the study. • HbA1c> 7.0 and <9.5% in Visit 1. • Body Mass Index (IMG) in the range of 22 - 45 kg / m2 in Visit 1.
Exclusion criteria
Exclusion criteria: • Pregnant or nursing women (breastfeeding). • GPA> 270 mg / dL (> 15.0 mmol / L). • Any of the following significant laboratory abnormalities: Clinically significant TSH outside the normal range at Visit 1. Clinically significant renal dysfunction indicated by serum creatinine levels> 1.5 mg / dL (132 pmol / L) for men and> 1.4 mg / dL (123 pmol / L) for women at Visit 1 or a history of abnormal creatinine clearance. High fasting triglycerides> 500 mg / dL at Visit 1 confirmed with repeated measurement within 3 working days. Alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 2 X upper limit of normal (ULN) in Visit 1, confirmed by a repeated measure within 3 working days. Total bilirubin> 2 x ULN and / or direct bilirubin> of ULN in Visit 1 confirmed by a repeated measurement within 3 working days. Hepatitis B surface antigen (HBsAg) positive. Hepatitis C antibody test (anti-HCV positive). Clinically significant laboratory abnormalities in the opinion of the researcher. • Congestive heart failure requiring pharmacological treatment. • A history of: Type 1 diabetes, diabetes that is the result of pancreatic injury or secondary forms of diabetes, eg, Cushing´s syndrome and acromegaly. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar condition (coma) in the last 6 months. Liver disease, such as cirrhosis or active chronic hepatitis B or C. • Any of the following in the last 6 months: Myocardial infarction (MI) (if the ECG of Visit 1 reveals patterns consistent with an IM and the date of the event cannot be determined, then the patient can enter the study at discretion of the researcher and the sponsor). Unstable angina. Coronary artery bypass surgery or percutaneous coronary intervention. Stroke • Any of the following ECG abnormalities: Torsades de pointes, clinically relevant and sustained ventricular tachycardia or ventricular fibrillation. Second degree AV block (Mobitz 1 and 2). Third degree AV block. Prolonged QTc (> 500 ms). • Treatment with any oral antidiabetic therapy other than metformin within 3 months prior to Visit 1. • Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent disease) in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the final available post-randomization evaluation obtained at any visit (scheduled or unscheduled), before or at the start of rescue medication use, until the visit of Week 24 inclusive. Measure:Change from baseline in HbA1c at the end point of Week 24. Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting plasma glucose measurement during the study. Measure:Changes at baseline after 24 weeks of fasting plasma glucose (GPA) treatment Timepoints:Week 24 ; Outcome name:Measurement of body weight during the study. Measure:Changes at baseline after 24 weeks of treatment on body weight. Timepoints:24 weeks ; Outcome name:The change in the average of minimum squares (adjusted average) from the baseline level for each treatment group, the difference in the average changes of minimum squares between each of the vildagliptin MR groups and the sitagliptin (vildagliptin group) MR - sitagliptin) will be obtained from the primary analysis model as well as the p-values for the treatment differences and the 95% confidence interval at two tails. Measure:Demonstration of the non-inferiority of vildagliptin MR added to metformin for the effect on the reduction of HbA1c compared to sitagliptin added to metformin Timepoints:24 weeks | — |
Countries
Argentina, Austria, Belgium, Finland, Germany, Greece, Guatemala, Hungary, Italy, Korea South, Latovia, Lithuania, Mexico, Norway, Peru, Poland, Portugal, Romania, Slovakia, Venezuela
Outcome results
None listed