None listed
Conditions
Interventions
Group 1 Type of group
Dapagliflozin tablets, Oral, 5.0 mg, once daily, up to 48 weeks + Pioglitazone tablets, ≥
Placebo matching Dapagliflozin tablets, Oral, 0 mg, once daily, up to 48 weeks + Pioglitazone tablets, ≥
30 mg, Once daily, up to 48 weeks
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: • Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control • All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5% • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L) • Body Mass Index ≤ 45.0 kg/m²
Exclusion criteria
Exclusion criteria: • MEF who do not want or are not able to use an acceptable method to avoid pregnancy during the entire period of the study. • Women who are pregnant or breastfeeding • Women with positive pregnancy test at enrollment or before administration of the experimental product. • Albumin: urine creatinine ratio (UACR)> 1800 mg / e (203.4 mg / mmol / Cr). • Aspartate Aminotransferase (AST)> 2.5 X normal upper limit (LSN). • Alanine Aminotransferase (ALT)> 2.5 X ULN. • Total serum bilirubin (BT)> 2 mg / dl (34.2 pmol / 1). • Serum creatinine (Ser)> 2.0 mg / dl • Clearance of Cr calculated 3XLSN. ; • Abnormal T4 values. An abnormal value of the thyroid-stimulating hormone (TSH) in the enrollment will be further evaluated for free T4. Subjects with abnormal free T4 values ​​will be excluded. • History of diabetes insipidus. • Symptoms of poorly controlled diabetes that would prevent participation in this trial, including, but not limited to, marked polyuria and polydipsia with more than 10% weight loss during the three months prior to enrollment, or other signs and symptoms. • History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. Measure:Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 Timepoints:From Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period. Measure:Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 Timepoints:From Baseline to Week 24 ; Outcome name:Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. Measure:Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 Timepoints:From Baseline to Week 24 ; Outcome name:Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams | — |
Countries
Argentina, Canada, India, Mexico, Peru, Philippines, Puerto Rico, Taiwan, United States
Contacts
Public ContactUrsula Noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed