The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
494
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
Time frame: Baseline and 18 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment
Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
Time frame: Baseline and 18, 54 and 78 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Time frame: Baseline, 18, 54 and 78 weeks
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment
Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Time frame: Baseline, 18, 54 and 78 weeks
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment
Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
Time frame: Baseline, 54 and 78 weeks
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment
Change from baseline in body weight after 18, 54 and 78 weeks of treatment
Time frame: Baseline, 18, 54, 78 weeks
Change From Baseline in Body Weight at Follow-up
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BI 10773 placebo
1245.33.01014 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1245.33.01047 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1245.33.01060 Boehringer Ingelheim Investigational Site
Fresno, California, United States
1245.33.01013 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1245.33.01008 Boehringer Ingelheim Investigational Site
Los Gatos, California, United States
1245.33.01019 Boehringer Ingelheim Investigational Site
National City, California, United States
1245.33.01055 Boehringer Ingelheim Investigational Site
Paramount, California, United States
1245.33.01012 Boehringer Ingelheim Investigational Site
Santa Ana, California, United States
1245.33.01054 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1245.33.01046 Boehringer Ingelheim Investigational Site
Bradednton, Florida, United States
...and 89 more locations
Change from baseline in body weight at follow up (82 weeks)
Time frame: Baseline and 82 weeks
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment
Change from baseline in HbA1c after 54 and 78 weeks of treatment
Time frame: Baseline, 54 and 78 weeks
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment
The occurrence of treat to target efficacy response, that is an HbA1c under treatment of \<7.0% After 18, 54, and 78 weeks of treatment
Time frame: Baseline, 18, 54 and 78 weeks