Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pisa
• Treatments: Dapagliflozin; Metformin; Saxagliptin

Criteria

Inclusion Criteria:

1. Males and females

2. Age = 35-70 years

3. BMI ≤ 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months

4. Type 2 diabetes (HbA1c > 7 % and < 10 %)

5. Metformin on stable dose (at least 1500 mg/day) for at least 12 weeks before screening and at study initiation.

6. 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:

1. Drugs known to affect glucose metabolism (other than metformin) for more than14 days during the 12 weeks before screening

2. Known Dapagliflozin and Saxagliptin Excipient Hypersensitivity

3. Type 1 Diabetes or History of Ketoacidosis

4. history of cancer of any type;

5. cerebrovascular or symptomatic peripheral vascular disease;

6. heart disease class III or IV NYHA;

7. 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

8. Liver function enzymes higher more than two times the upper limit

9. Ongoing urinary tract infection

10. drug or alcohol abuse;

11. life expectancy <3 yrs

12. blood pressure >160/100 mmHg

13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter

14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)

15. Women who are pregnant or breastfeeding

16. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures