None listed
Conditions
Interventions
Subjects must be on a stable dose of metformin (≥
1500 mg/day for ≥
8 weeks) at V1. Subjects who meet all other enrollment criteria will be eligible to enter the 2-week single-blind placebo run-in period (V2 to V3).
At V3 subjects will enter the 24-week, double-bli
in this case the investigator should continue to assess at subsequent visits whether the subject may be up-titrated. Dapagliflozin 10 mg/matching placebo may be down-titrated to dapagliflozin 5 mg/mat
1500 mg/day) while receiving blinded study drug during the double-blind treatment period.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
25 Years to 100 Years
Inclusion criteria
Inclusion criteria: At V1: 1 Have T2DM and be ≥25 years old 2 Have eGFR ≥60 mL/min/1.73 m2 and <90 mL/min/1.73 m2 3 Be on metformin monotherapy ≥1500 mg/day for ≥8 weeks with A1C ≥7.0% and ≤9.0% (≥53 mmol/mol and ≤75 mmol/mol) at V1 4 BMI ≥18.0 kg/m2 5 Have signed the ICF 6 Comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 7 Subject is a male or female not of reproductive potential or accepts to use (or her partner) two methods of contraception to avoid pregnancy throughout the study At V2: 8 Have eGFR ≥60 mL/min/1.73 m2 and <90 mL/min/1.73 m2, and within 10 mL/min/1.73 m2 of V1value At V3: 9 Be ≥80% compliant with placebo run-in medication
Exclusion criteria
Exclusion criteria: At V1 1 History of type 1 diabetes mellitus or ketoacidosis 2 History of secondary causes of diabetes 3 Hypersensitivity or intolerance to DPP-4 or SGLT2 inhibitor 4 Treated with no acceptable drugs within 12 weeks of V1 5 Weight loss medication 6 Bariatric surgery within 1 year of V1 7 Is not weight stable 8 Medication associated with weight changes 9 Cardiovascular disorder 10 Risk for volume depletion, hypotension and/or electrolyte imbalances 11 History of malignancy 12 HIV 13 Hematological disorder 14 History of active liver disease 15 Malabsorption condition 16 Hyperthyroidism 17 Thyroid replacement therapy 18 Tto with corticosteroids 19 Tto with non-steroidal anti-inflammatory drugs 20 Surgical procedure 21 Unstable blood pressure 22 Other severe acute or chronic medical or psychiatric condition 23 Exclusionary laboratory value 24 Participated in trials with investigational drug 25 Urine pregnancy test + 26 Pregnant or breast-feeding 27 Hormonal therapy 28 Alcohol intake 29 Donated blood or products 30 Is or has an immediate family member of site or sponsor staff At V2: 31 Abnormal ECG 32 FPG consistently 33 Urine pregnancy test + 34 Fasting TG level >600 mg/dL At V3: 35 FFSG 260mg/dL 36 Urine pregnancy test + 37 Non acceptable medication 38 Unstable blood pressure 39 New medical condition
Countries
Argentina, Australia, Brazil, Canada, Colombia, Estonia, Finland, Germany, Hungary, Ireland, Korea South, Latovia, Lithuania, Mexico, New Zealand, Norway, Peru, Romania, Russian Federation, South Africa, Spain, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed