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WithdrawnNCT02719132FLORAUpdated May 20, 2016

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

A Phase 4 interventional study of Dapagliflozin and Metformin in Diabetes Mellitus Type 2, sponsored by AstraZeneca. Withdrawn. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-05-20.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Diabetes Mellitus Type 2

Keywords

  • Diabetes Mellitus type 2, dapagliflozin, quality of life
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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 · Drug: Metformin

  • 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 · Drug: Metformin

Interventions

  • DrugDapagliflozin

    Dapagliflozin, 10 mg

    Also known as: Forxiga

  • DrugMetformin

    Metformin, up to 2500 mg

    Also known as: Glucophage

06

What researchers measure

Primary outcomes

  1. Composite endpoint including quality of life score

    Change in the overall quality of life, obesity-specific quality of life and treatment satisfaction in the course of the therapy by the end of each 24-week treatment period compared to the quality of life, obesity-specific quality of life and treatment satisfaction at baseline.

    Time frame: 48 weeks

Secondary outcomes

  1. Change in HbA1c level

    Change in HbA1c level will be assessed as mean change in the course of the treatment compared to baseline.

    Time frame: 48 weeks

  2. Change in body weight

    Change in body weight will be assessed as mean change in body weight, mean percentage change in body weight and mean change in body mass index compared to baseline and as proportion of patients with body weight decreased by ≥5% during the treatment phase.

    Time frame: 48 weeks

  3. Change in waist circumference

    Change in waist circumference will be assessed as mean change and mean percentage change in waist circumference during the treatment phase compared to baseline.

    Time frame: 48 weeks

  4. Change in fasting plasma glucose

    Change in fasting plasma glucose will be assessed as mean change in fasting plasma glucose during the treatment phase compared to baseline.

    Time frame: 48 weeks

  5. Proportion of patients

    Proportion of patients who achieved therapeutic glycaemic response (HbA1c ≤7%).

    Time frame: 48 weeks

Other outcomes

  1. ECG variables

    ECG records including the following variables: heart rate (beats per minute), QT (msec), QTcB (msec), sinus heart rate (yes/no)

    Time frame: 48 weeks

  2. number of episodes of hypoglycaemia and ketoacidosis

    number of episodes of hypoglycaemia and ketoacidosis

    Time frame: 48 weeks

  3. change in glomerular filtration rate

    change in glomerular filtration rate compared to baseline at Screening

    Time frame: 48 weeks

  4. laboratory values changes

    laboratory values (ALT, AST, total bilirubin, and creatinine)

    Time frame: 48 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02719132
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 25, 2016
Start date
Jul 2016
Primary completion
Nov 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
May 20, 2016

Study contacts

Marina Shestakova, Professor
principal investigator · Russian Federal Research Endocrinology center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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