Effect of DapagliFLOzin on Quality of Life in Patients with Type 2 Diabetes in a Real Clinical PrActice - FLORA

Study identifier:D1690C00043

ClinicalTrials.gov identifier:NCT02719132

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Multicentre Randomised Open-Label Crossover 2-Period 2 Treatment Clinical Trial to Evaluate Effect of Dapagliflozin 10 mg once daily on the Quality of Life in Patients with Type 2 Diabetes

Medical condition

Diabetes mellitus type 2

Phase

Phase 4

Healthy volunteers

Study drug

Dapagliflozin, Metformin

Sex

All

Estimated Enrollment

820

Study type

Interventional

Age

18 Years - 74 Years

Date

Study Start Date: 01 Jul 2016

Estimated Primary Completion Date: 01 Nov 2017

Estimated Study Completion Date: 01 Nov 2017

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: Arm 1 Arm 1 – therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks (Treatment Regimen 1) followed by metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks (Treatment Regimen 2)	Drug: Dapagliflozin Dapagliflozin, 10 mg Other Name: Forxiga Drug: Metformin Metformin, up to 2500 mg Other Name: Glucophage
Active Comparator: Arm 2 Arm 2 – metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks (Treatment Regimen 2) followed by therapy with dapagliflozin 10 mg once daily in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks (Treatment Regimen 1)	Drug: Dapagliflozin Dapagliflozin, 10 mg Other Name: Forxiga Drug: Metformin Metformin, up to 2500 mg Other Name: Glucophage

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Nikolay Suvorov