None listed
Conditions
Interventions
Group 1 Type of group
Saxagliptin 5mg oral tablet once daily
Group name:Group 2 Type of group
Metformin XR 500mg oral tablet once daily
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: • Provision of informed consent before any specific study procedure. • Men and women 18 to 78 years old. Fertile women (WOCBP) should be using an appropriate contraceptive method to prevent pregnancy throughout the study [and for up to 4 weeks after the last dose of the research product] so that the risk of pregnancy is minimized. • Subjects with a diagnosis of DMT2 with a stable dose of Metformin IR or XR> 850 mg and 7.5% and 7.0% and 7.0% and 1.0 mg / ml at the screening visit. • Body mass index <45 kg / m ^ at the screening visit.
Exclusion criteria
Exclusion criteria: • Participation in the planning and / or conduct of the study (applies to both AstraZeneca and BMS staff and to the study site). • Prior enrollment in the present study. • WOCBP who do not want or cannot use an acceptable method to prevent pregnancy during the total period of the study [and for up to 4 weeks after the last dose of the research product]. • Pregnant or breastfeeding women. • Women with positive pregnancy test at enrollment or before administration of the research product. • Sexually active fertile men who do not use effective birth control if their partners are WOCBP. • Symptoms of inadequate control of DMT2 including, but not limited to marked polyuria and polydipsia, with a weight loss greater than 10% during the 3 months prior to screening or other signs and symptoms. • History of diabetic ketoacidsosis or hyperosmolar non-ketosic coma. • Insulin therapy within the year of screening. • Significant cardiovascular history • History of unstable or progressive kidney disease • History of alcohol or drug abuse during the last year • Important unstable psychiatric disorder • History of hemoglobinopathies (sickle cell anemia or thalassemia, sideroblastic anemia). • Donation of blood or plasma to a blood bank within three months of screening. • Administration of any investigational drug or participation in a clinical investigation within 30 days of the planned enrollment of this study. • Any condition that, in the opinion of the Investigator, could cause the subject to not complete the study or that may imply a significant risk to the subject. • Active liver disease and / or significant abnormal liver function defined as AST> 2 X LSN and / or ALT> 2 x LSN and / or total serum bilirubin> 2.0 g / dl. • History of evidence of positive serology of current infectious liver disease including anti-HAV (IgM), HbsAg, or anti-HCV. Subjects that may have isolated anti Hbs positive may also be included. • Serum creatinine (Ser)> 1.5 mg / dl (132.6 pmol / 1) for men and> 1.4 mg / dl (123.8 pmol / 1) for women. • Creatinine kinase> 3 x LSN • Anemia, of any etiology, defined as hemoglobin 80% and <120%) duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. Measure:Change in HbA1c Level From Baseline to Week 18 (LOCF) Timepoints:Baseline to week 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. Measure:Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF) Timepoints:Baseline to week 18 ; Outcome name:Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. Measure:Change in FPG From Baseline to Week 18 (LOCF) Timepoints:Baseline to week 18 ; Outcome name:Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set) Measure:Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1) Timepoints:Week 18 (LOCF) | — |
Countries
Colombia, Costa Rica, Mexico, Peru, United States
Contacts
Public ContactEdward Ramirez
ASTRAZENECA PERU S.A.
Outcome results
None listed