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Diabetes Mellitus Type 2Phase 4FLORANCT02719132

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

A Phase 4 study testing Dapagliflozin and Metformin in people with Diabetes Mellitus Type 2, run by AstraZeneca.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Dapagliflozin and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2016to Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

About this study

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

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.
Keywords
Diabetes Mellitus type 2, dapagliflozin, quality of life
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Forxiga

    Dapagliflozin, 10 mg

  • MetforminDrug

    Also called Glucophage

    Metformin, up to 2500 mg

Study groups in NCT02719132
Study groupRoleWhat they receive
Arm 1ExperimentalArm 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)
Receives: Drug: Dapagliflozin; Drug: Metformin
Arm 2Active comparatorArm 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)
Receives: Drug: Dapagliflozin; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 weeks

Secondary outcomes (5)

  1. Change in HbA1c level

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 48 weeks

  5. Proportion of patients

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

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionNov 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02719132
Sponsor's protocol ID
D1690C00043
Acronym
FLORA
Status last verified
May 2016
First submitted
21 Mar 2016
Last updated
20 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin and Metformin in people with Diabetes Mellitus Type 2, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint including quality of life score (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02719132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.

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