AzTrials
AzTrials

Type 2 DiabetesforREALNCT01944618

forREAL: FORXIGA PRESCRIPTION EVENT MONITORING PROGRAM (PEMP)

An observational study of Type 2 Diabetes, run by AstraZeneca at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Forxiga
Type of treatment
Pill or oral medicine
How many people
5,000 participants
Where
1 siteAustralia
Study dates
Oct 2013to Oct 2015
Phase
Observational
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Type 2 Diabetes whom the Healthcare professional (HCP) would consider as suitable candidates for Forxiga treatment will be invited to participate in the program during routine clinical assessment

Who may be able to join

  • Patients with Type 2 Diabetes who are:
  • Prescribed Forxiga for glycaemic management AND
  • Who have the ability to provide informed consent

Who cannot join

  • Patients with whom use of Forxiga is contraindicated:
  • Patients with Type 1 Diabetes
  • Patients with moderate to severe renal impairment [Creatinine clearance (CrCl) <60 mL/min or estimated glomerular filtration rate (eGFR) <60mL/min/1.73m²]
  • Additional exclusion criteria:
  • Age >75 years
  • Concomitant use of loop diuretics or pioglitazone
  • Patients who are currently on another SGLT2 inhibitor

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Local Institution

    Clayton, Victoria, VIC 3168

Other trials in Australia

About this study

Official title: forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM

The study purpose is to assess adverse events in patients with Type 2 diabetes who have newly been prescribed Forxiga for the management of glycemic control

Read the detailed description

Observational Model: Other: A post-marketing evaluation of the safety of Forxiga through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice

Conditions
Type 2 Diabetes
Being tested
Forxiga
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.

  • ForxigaDrug

    Also called Dapagliflozin

    FORXIGA is a prescription medicine used with diet, exercise and sometimes other medicines (which may include metformin; insulin; a sulfonylurea medicine such as gliclazide, glimepiride and glibenclamide; or a dipeptidyl peptidase-4 inhibitor [DPP 4 inhibitor] such as sitagliptin or saxagliptin) to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus.

Study groups in NCT01944618
Study groupRoleWhat they receive
T2DM patients newly prescribed ForxigaA post-marketing evaluation of the safety of Forxiga (10 mg tablets, orally once daily for 6 months) through an observational prescription adverse event monitoring program (registry-based monitoring program) is warranted to assess real-world incidence of adverse events in routine clinical practice.
Receives: Drug: Forxiga

What is being measured

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

  1. Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers

    Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice

    Measured: Up to 6 months

  2. Any early adverse effects as a result of drug interactions in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice

    Measured: Up to 6 months

  3. Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice

    Measured: Up to 6 months

Secondary outcomes (4)

  1. Rate of prescribing of Forxiga after its introduction to routine Australian clinical practice

    Measured: Upto 6 months

  2. Indication for prescription of Forxiga in routine Australian clinical practice

    Measured: Upto 6 months

  3. Change in efficacy and safety variables after treatment with Forxiga for at least 3 months

    Including:

    • HbA1c
    • Weight
    • Systolic blood pressure
    • Diastolic blood pressure
    • Heart rate
    • Serum creatinine
    • Estimated glomerular filtration rate
    • Liver function tests [Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or bilirubin]

    Measured: Baseline and 3 months

  4. Subgroup analyses may be conducted for selected safety parameters

    Subgroups to be evaluated will include gender, age, diabetes duration, concomitant medication, past medical history, and measured laboratory variables (if available)

    Measured: Upto 6 months

Timeline

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

  1. First posted17 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: Participant Data obtained to 30Sep2015: Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.

Resources

More details

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

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944618
Sponsor's protocol ID
MB102-209
Acronym
forREAL
Status last verified
Sep 2016
First submitted
13 Sep 2013
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by AstraZeneca at 1 site in Australia.

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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study was stopped early (reason given: Participant Data obtained to 30Sep2015: Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.). Results are not available in the source record.

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?

Incidence rates of adverse events, specifically genital infections, urinary tract infections, increased haematocrit, renal impairment, hepatic impairment, bone fractures and cancers, in particular breast, bladder, and prostate cancers (time frame: Up to 6 months). The study lists 3 primary outcomes in all. 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 NCT01944618.

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 13 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in