The objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary objective of efficacy evaluation is planned after 24 weeks of treatment. The study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
708
Empagliflozin active
Empagliflozin placebo
Empagliflozin / Linagliptin 25/5 mg Dose FDC active
Change From Baseline of HbA1c After 24 Weeks of Treatment.
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term "baseline" was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as "pre-treatment". Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference. Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial.
Time frame: Baseline and 24 weeks
Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.
Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.
Time frame: Baseline and 24 weeks
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Empagliflozin active
Empagliflozin / Linagliptin 10/5 mg Dose FDC active
Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
Empagliflozin active
Empagliflozin active
Empagliflozin active
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Empagliflozin placebo
Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
Empagliflozin active
Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
1275.10.01019 Boehringer Ingelheim Investigational Site
Chino, California, United States
1275.10.01008 Boehringer Ingelheim Investigational Site
Huntington Beach, California, United States
1275.10.01003 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1275.10.01024 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1275.10.01002 Boehringer Ingelheim Investigational Site
Sylmar, California, United States
1275.10.01011 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1275.10.01009 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1275.10.01023 Boehringer Ingelheim Investigational Site
Oviedo, Florida, United States
1275.10.01006 Boehringer Ingelheim Investigational Site
Tamarac, Florida, United States
1275.10.01017 Boehringer Ingelheim Investigational Site
Conyers, Georgia, United States
...and 104 more locations