The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
495
Change From Baseline in HbA1c After 12 Weeks of Treatment
Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
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. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.
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%) based on logistic regression
Time frame: Baseline and 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%) based on logistic regression
Time frame: Baseline and 12 weeks
Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
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1245.10.10026 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
1245.10.10001 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
1245.10.10011 Boehringer Ingelheim Investigational Site
Pasadena, California, United States
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Spring Valley, California, United States
1245.10.10027 Boehringer Ingelheim Investigational Site
Walnut Creek, California, United States
1245.10.10004 Boehringer Ingelheim Investigational Site
Clearwarter, Florida, United States
1245.10.10021 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1245.10.10005 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1245.10.10019 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
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Saint Cloud, Florida, United States
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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), FPG in mg/dl. 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) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.
Time frame: Days 28, 56 and 84