The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
408
Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.
Time frame: Baseline and 12 weeks
Change of FPG From Baseline After 12 Weeks of Treatment
Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups.
Time frame: Baseline and 12 weeks
Change of HbA1c From Baseline Over Time
Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.
Time frame: Baseline and weeks 4, 8 and 12
Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).
Time frame: 12 weeks
Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).
Time frame: 12 weeks
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
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1245.9.54001 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54002 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54007 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54008 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54009 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54010 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1245.9.54004 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1245.9.54003 Boehringer Ingelheim Investigational Site
Mendoza, Argentina
1245.9.54005 Boehringer Ingelheim Investigational Site
Salta, Argentina
1245.9.54006 Boehringer Ingelheim Investigational Site
Salta, Argentina
...and 64 more locations
Results for change of FPI from baseline at week 12 based on ANCOVA.
Time frame: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.
Time frame: Baseline and 12 weeks
Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.
Time frame: Baseline and 12 weeks
Change of Body Weight After 12 Weeks of Treatment
Results for change of body weight after 12 weeks of treatment based on ANCOVA.
Time frame: Baseline and 12 weeks
Trough Concentrations of Empagliflozin in Plasma
Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma
Time frame: Days 28, 56 and 84