Trial | NCT02719132  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
The study will comprise the following phases: Screening, Treatment Period 1 and Treatment Period 2.

After screening examinations and assessments, all patients enrolled will be randomly assigned in equal proportion (1:1) to either study arm:

Arm 1:

Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for 24 weeks during Treatment Period 1
Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for further 24 weeks during Treatment Period 2

Arm 2 (the same treatment phases in reverse order):

Patients will be on metformin monotherapy with dose titrated up to 2,500 mg/day for 24 weeks during Treatment Period 1
Patients will take dapagliflozin 10 mg in combination with metformin ≤ 1,500 mg (daily dose) for further 24 weeks during Treatment Period 2 Following the randomisation procedure, patients will receive investigational products at each visit as scheduled by Treatment Period 1. After the Randomisation Visit (Visit 2), the patient should attend the study centre for Visits 3, 4, and 5 (Day 28, Day 86, and Day 168, respectively) for efficacy and safety assessments. At Visit 5 (Day 168), the patient will receive investigational products as required by Treatment Period 2. Further Visits 6, 7 and 8 will be scheduled on Day 196, Day 252, Day 336, respectively.
Study Started
Jul 31
2016
Primary Completion
Nov 30
2017
Anticipated
Study Completion
Nov 30
2017
Anticipated
Last Update
May 20
2016
Estimate

Drug Dapagliflozin

Dapagliflozin, 10 mg

  • Other names: Forxiga

Drug Metformin

Metformin, up to 2500 mg

  • Other names: Glucophage

Arm 1 Experimental

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)

Arm 2 Active Comparator

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)

Criteria 

Inclusion Criteria:

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

A voluntary informed consent form for participation in the study signed by the patient prior to any study-specific procedures
Male and female patients of 18-74 years of age
Diagnosed type 2 diabetes
Therapy with metformin at a stable dose ≤1,500 mg/day for at least 8 weeks before enrolment
HbA1c >7.0% and ≤10% at the Screening Visit
C-peptide ≥1.0 ng/ml at the Screening Visit
Body mass index ≤45.0 kg/m² at the Screening Visit
For women of childbearing potential - use of reliable birth control methods
Ability to complete study-specific procedures
Ability to complete questionnaires

Exclusion Criteria:

Type 1 diabetes
Diabetic ketoacidosis at Screening
AST and/or ALT > 3 × upper limit of normal at Screening
Total serum bilirubin > 34.19 μmol/l at Screening
Decompensated diabetes mellitus (HbA1c >10% at Screening)
Patients with moderate to severe renal impairment (CrCl <60 ml/min or <60 ml/min/1.73 m2 at Screening) or terminal renal insufficiency
Severe concomitant diseases or severe cardiovascular, renal, hepatic, hematologic, endocrine, mental or rheumatic pathology
Malignancy within 5 years before enrolment
Acute (including viral and infectious) diseases within 1 month before the Screening Visit.
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
History of acute myocardial infarction or stroke within 6 months before the Screening Visit or during the study. Heart failure (NYHA III-IV)
Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the Screening Visit.
For women of childbearing potential - a positive pregnancy test or the patient is breast-feeding or planning pregnancy during the study
History of Hepatitis B and C or HIV
Individual hypersensitivity to any component of the investigational product (dapagliflozin)
Treatment with sodium-dependent glucose cotransporter inhibitors (SGLT2) has been administered within 3 months prior to enrolment or is planned during the study.
Loop diuretics have been administered for 3 months before the Screening Visit or are planned during the study.
Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption
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
The patient is a subject of other studies within 3 months before enrolment
No Results Posted