Effect of DapagliFLOzin on Quality of Life in Patients With Type 2 Diabetes in a Real Clinical PrActice

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomised, open-label, crossover, 2-period comparative phase IV study.

The primary objective is to compare the effect of dapagliflozin 10 mg once daily in combination with metformin at a daily dose of ≤1,500 mg vs. metformin monotherapy with dose titrated up to 2,500 mg/day on the overall quality of life, obesity-specific quality of life and treatment satisfaction in patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

For inclusion in the study patients should fulfil ALL the criteria listed below:

1. A voluntary informed consent form for participation in the study signed by the patient prior to any study-specific procedures

2. Male and female patients of 18-74 years of age

3. Diagnosed type 2 diabetes

4. Therapy with metformin at a stable dose ≤1,500 mg/day for at least 8 weeks before enrolment

5. HbA1c >7.0% and ≤10% at the Screening Visit

6. C-peptide ≥1.0 ng/ml at the Screening Visit

7. Body mass index ≤45.0 kg/m² at the Screening Visit

8. For women of childbearing potential - use of reliable birth control methods

9. Ability to complete study-specific procedures

10. Ability to complete questionnaires

Exclusion Criteria:

1. Type 1 diabetes

2. Diabetic ketoacidosis at Screening

3. AST and/or ALT > 3 × upper limit of normal at Screening

4. Total serum bilirubin > 34.19 μmol/l at Screening

5. Decompensated diabetes mellitus (HbA1c >10% at Screening)

6. Patients with moderate to severe renal impairment (CrCl <60 ml/min or <60 ml/min/1.73 m2 at Screening) or terminal renal insufficiency

7. Severe concomitant diseases or severe cardiovascular, renal, hepatic, hematologic, endocrine, mental or rheumatic pathology

8. Malignancy within 5 years before enrolment

9. Acute (including viral and infectious) diseases within 1 month before the Screening Visit.

10. Development of severe acute diseases during the study which significantly affect the benefit/risk ratio for the subject or affecting study efficacy/safety assessment criteria

11. History of acute myocardial infarction or stroke within 6 months before the Screening Visit or during the study. Heart failure (NYHA III-IV)

12. Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the Screening Visit.

13. For women of childbearing potential - a positive pregnancy test or the patient is breast-feeding or planning pregnancy during the study

14. History of Hepatitis B and C or HIV

15. Individual hypersensitivity to any component of the investigational product (dapagliflozin)

16. Treatment with sodium-dependent glucose cotransporter inhibitors (SGLT2) has been administered within 3 months prior to enrolment or is planned during the study.

17. Loop diuretics have been administered for 3 months before the Screening Visit or are planned during the study.

18. Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption

19. The patient is unable to follow study procedures and attend the study centre for scheduled study visits or is going to relocate within the protocol-specific timelines

20. The patient is a subject of other studies within 3 months before enrolment