This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
939
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
1, 2, or 4 mg, orally Opaque gray capsule
Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
Change in HbA1c from baseline (week 0) to week 52.
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Patients With at Least One Episode of Confirmed Hypoglycaemia
Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose \<=50 mg/dL) during the double-blind treatment period
Time frame: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Total Body Weight From Baseline at Week 52
Change in body weight from baseline (week 0) to week 52
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Change in FPG from baseline (week 0) to week 52
Time frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis
Time to Rescue
The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period
Time frame: Over the 52 week treatment period
Number of Patients Rescued
Number (%) of patients rescued.
Time frame: Over the 52 week treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
Does not contain active ingredient, orally. Opaque gray capsule
Research Site
Hodonín, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Jílové u Prahy, Czechia
Research Site
Ostrava - Belsky Les, Czechia
Research Site
Pardubice, Czechia
Research Site
Plzen - Severni Predmesti, Czechia
Research Site
Praha Klanovice, Czechia
Research Site
Přelouč, Czechia
Research Site
Uherské Hradiště, Czechia
Research Site
Zlín, Czechia
...and 163 more locations