Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in… (NCT03714594) | Clinical Trial Compass
CompletedPhase 2
Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.
Italy48 participantsStarted 2018-07-24
Plain-language summary
A phase IV, randomized, double-blind, single center pilot study in subjects with type 2 diabetes poorly controlled with metformin therapy will be randomized to receive, on top of metformin: saxagliptin (5 mg/day) and dapagliflozin (10 mg/day) (Group 1);saxagliptin (5 mg/day) and placebo (Group 2); dapagliflozin (10 mg/day) and placebo (Group 3) for 4 weeks.
Who can participate
Age range35 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males and females
✓. Age = 35-70 years
✓. BMI ≤ 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
✓. Type 2 diabetes (HbA1c \> 7 % and \< 10 %)
✓. Metformin on stable dose (at least 1500 mg/day) for at least 12 weeks before screening and at study initiation.
✓. Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study.. 7.7. Subjects are capable of giving informed consent
Exclusion criteria
✕. Drugs known to affect glucose metabolism (other than metformin) for more than14 days during the 12 weeks before screening
✕. Known Dapagliflozin and Saxagliptin Excipient Hypersensitivity
✕. Type 1 Diabetes or History of Ketoacidosis
✕. history of cancer of any type;
✕. cerebrovascular or symptomatic peripheral vascular disease;
✕. heart disease class III or IV NYHA;
✕. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m 2 or serum creatinine \> 1.5mg/dL in men or \>1.4mg/dL in women