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NCT01944618: forREAL
forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM
trial testing Forxiga in Type 2 Diabetes in 5,000 participants. Terminated before completion.
1 October 2015
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 1 October 2013 |
| Primary completion | 1 October 2015 |
| Estimated completion | 1 October 2015 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Forxiga — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Assessed in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice -
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
Time frame: Up to 6 months -
Incidence rates of spontaneously reported hypoglycaemia in patients with Type 2 diabetes who are treated with Forxiga in routine Australian clinical practice
Time frame: Up to 6 months
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01944618
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04193566 — Acute Effects of SGLT2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes · Phase 4 · completed
- NCT03407196 — Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey · completed
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
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Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01944618 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 12 September 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01944618.
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