Type 2 Diabetes inadequately controlled with dapagliflozin with or without metformin
Conditions
Brief summary
Change from baseline to week 24 in HbA1c.
Detailed description
Change from baseline to week 24 in centralised fasting plasma glucose (FPG), Proportion of participants at week 24 with: • HbA1c < 7.0% • HbA1c ≤ 6.5% • HbA1c < 7% without clinically important and/or severe hypoglycaemia, Proportion of participants requiring rescue therapy over 24 weeks, Adverse events, including hypoglycaemic events, genital infections, and urinary tract infections (UTIs), Vital signs (SBP, DBP, HR), body weight and clinical laboratory measures (biochemistry and haematology)
Interventions
DRUGDIAMICRON 60MG
DRUGcomprimé sécable à libération modifiée
DRUGPlacebo S05762
DRUGMETFORMIN
DRUGForxiga 10 mg film-coated tablets
Sponsors
Institut De Recherches Internationales Servier IRIS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 24 in HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 24 in centralised fasting plasma glucose (FPG), Proportion of participants at week 24 with: • HbA1c < 7.0% • HbA1c ≤ 6.5% • HbA1c < 7% without clinically important and/or severe hypoglycaemia, Proportion of participants requiring rescue therapy over 24 weeks, Adverse events, including hypoglycaemic events, genital infections, and urinary tract infections (UTIs), Vital signs (SBP, DBP, HR), body weight and clinical laboratory measures (biochemistry and haematology) | — |
Countries
Bulgaria, Hungary, Latvia, Lithuania, Poland
Outcome results
None listed