FORXIGA® (dapagliflozin) is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1
FORXIGA® (dapagliflozin) proven clinical trial data
Significant results demonstrated across 7 randomised controlled trials3,6-10 up to 4 years in duration11
Reductions in HbA1c with FORXIGA® (dapagliflozin) when added to metformin across baselines3,6-10*
*Phase 3/4 studies with HbA1c reductions as a primary endpoint.3,6-10
-1.32% reduction was a secondary endpoint in Bailey CJ et al.6
N.B. It is not possible to directly compare results from different trials
A 24-week, multicentre,
Patients had to be stable on metformin therapy (≥1500 mg/day) for ≥8 weeks before screening and have C-peptide concentrations ≥1.0 ng/mL and a body mass index ≤45.0 kg/m2 at screening. At the beginning of a 4-week lead-in period, patients who had been on stable metformin therapy for at least 8 weeks before screening were switched to the nearest metformin
The primary endpoint was the adjusted mean change from baseline in HbA1c after 24 weeks of double-blind treatment. Secondary endpoints were adjusted mean change from baseline at 24 weeks in 2-h postprandial glucose, adjusted mean change from baseline at 24 weeks in fasting plasma glucose, adjusted mean proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% (53 mmol/mol), after 24 weeks, and the adjusted mean change from baseline in
Safety assessments included adverse events,
This was a 52-week
After a 2-week, single-blind, placebo lead-in period, patients were
The primary endpoint was
Safety assessments included adverse events (of special interest urinary tract and genital infections), hypoglycaemic events, laboratory abnormalities, and vital signs.
Values for the additional 104-week extension (to week 208) is now available.11
Eligible patients completed a 6-week, single-blind, placebo lead-in period during which they were maintained on open-label metformin at their pre-enrolment dose (≥1500 mg/day). Patients completing the lead-in period were
The primary endpoint was mean change from baseline in HbA1c at week 24 for each FORXIGA®(dapagliflozin) group vs placebo. Secondary endpoints included changes from baseline at week 24 in fasting plasma glucose, 2-hour postprandial glucose, total body weight, and the proportion of patients achieving a therapeutic glycaemic response (HbA1c <7.0%).
Safety assessments included adverse events, changes in blood pressure and
A 52-week, multicentre,
The primary outcome
Safety assessments included adverse events (of special interest urinary tract and genital infections and ketoacidosis) and
A phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group, 24-week clinical study, plus a 78-week extension period, to evaluate the efficacy and safety of FORXIGA® (dapagliflozin) 10 mg + metformin (>1500 mg/day) vs placebo + metformin (>1500 mg/day) in adult patients with type 2 diabetes who had inadequate glycaemic control.
Patients were enrolled into a 2-week, single-blind, lead-in period in which patients received placebo to assess compliance. Patients who successfully completed the lead-in period were randomly assigned 1:1:1:1 by a central interactive voice response system to double-blinded groups of once-daily FORXIGA® (dapagliflozin) 2.5 mg, 5 mg, or 10 mg, or matching placebo before the morning meal for 24 weeks. Randomisation was stratified by investigation site, and randomisation schedules were computer-generated.
The primary outcome was change from baseline in HbA1c at 24 weeks. Key secondary endpoints included changes in fasting plasma glucose concentration and total body weight at week 24, proportion of patients achieving a therapeutic glycaemic response (defined as HbA1c <7% (53 mmol/mol) at week 24, and change in HbA1c percentage at week 24 for patients with a baseline HbA1c of 9% (75 mmol/mol or more).
Safety assessments included adverse events (of special interest urinary tract and genital infections), changes in blood pressure and hypoglycaemic events. Outcomes for the 78-week extension (to week 102) were presented by Bailey CJ et al. at the 71st Scientific Sessions of the American Diabetes Association 2011.
DURATION-8 was a 28 week, multicentre, double-blind,
Safety assessments included adverse events, laboratory abnormalities, vital signs, and