None listed
Conditions
Interventions
Group 1 Type of group
Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
Group name:Group 4 Type of group
Each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin will be given with protocol-specified doses of metformin immediate release.
Sponsors
Janssen Research & Develoment, LLC,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Men and women> 18 and 110 mg / dl (6.1 mmol / i) and 80% compliance ( by tablet count) with placebo capsules to single blind.
Exclusion criteria
Exclusion criteria: • History of diabetic ketoacidosis, DMTl, pancreas or B cell transplantation, or diabetes after pancreatitis or pancreatectomy • Repeated GPA (ie, 2 or more over a period of one week) and / or fasting GSAC measurements> 270 mg / dl (15 mtnol / l) during the pre-treatment phase, despite reinforcements of guidance on diet and exercise • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study • History of one or more severe hypoglycemic episodes within 6 months prior to selection • History of hereditary galactose glucose malabsorption or primary renal glycosuria • Inadequately controlled thyroid abnormality, ongoing (eg, a subject knows that it has a thyrotrophin [TSH] value of 10 mUI / l) • In any PPARy agonist (eg, a liazolidinedione (TZD) [pioglitazone or rosiglitazone]) or ongoing insulin therapy within 12 weeks prior to the screening visit • Current food changes or significant weight loss or gain within 12 weeks prior to the selection visit »defined as a 5% increase or decrease in body weight as measured by the clinic or, if not available, the subject report • Kidney disease that requires treatment with immunosuppressive therapy or history of dialysis or kidney transplant • Myocardial infarction, unstable angina, revascularization procedure (eg, stent or bypass surgery) or stroke within 3 months prior to selection, or planned revascularization procedure, or subject with a history of Class III heart disease- IV of the New York Heart Association (NYHA) (refer to Annex 4, New York Heart Association, Classification of Heart Disease, for a description of the classes). • 12-lead ECG findings that require urgent diagnostic evaluation or intervention (eg, new clinically important arrhythmia or conduction disorder) • Uncontrolled hypertension (ie, an average of 3 sitting blood pressure readings, with a diastolic blood pressure of> 100 mmHg or a systolic blood pressure of> 160 mmHg) at Week -2. • History of surface antigen for Hepatitis B or Hepatitis C antibody positive (unless associated with persistently documented normal / stable ranges of levels of aspartate aminotransferase [AST] and ALT) or other clinically active liver disease. • History of previous bariatric surgical procedure within 3 years prior to the selection visit • Estimated glomerular filtration rate (eGFR) 1.4 mg / di (124 ^ mol / l) in men and> 1.3 mg / dl (l 15 umol / l) in women • Fasting serum triglycerides> 600 mg / dl (6.74 mmol / L) in the selection (or next visits if you are not fasting)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. Measure:Change in HbA1c From Baseline to Week 26 Timepoints:Day 1 (Baseline) and Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo. Measure:Percentage of Patients With HbA1c <7% at Week 26 Timepoints:Week 26 ; Outcome name:The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. Measure:Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 Timepoints:Day 1 (Baseline) and Week 26 ; Outcome name:The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. Measure:Change in 2-hour Post-prandial Glucose From Baseline to Week 26 Timepoints:Day 1 (Baseline) and Week 26 ; Outcome name:The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. Measure:Percent Change in Body Weight From Baseline to Week 26 Timepoints:Day 1 (Baseline) and Week 26 ; Outcome name:The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. Measure:Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 Timepoints:Day 1 (Baseline) and Week 26 ; Outcome name:The table below shows the least-sq | — |
Countries
Argentina, Brazil, Bulgaria, Colombia, Costa Rica, Estonia, Greece, India, Latovia, Malasya, Mexico, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, Slovakia, Sweden, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactPaloma de Almenara
RPS PERU S.A.C
Outcome results
None listed