Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mgDrug: Placebo identical to BI 1356 5mg
- Registration Number
- NCT00622284
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1560
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1356 5mg, once daily Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride BI 1356 5mg, once daily BI 1356 patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride Glimepiride Placebo identical to BI 1356 5mg patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US) Glimepiride Glimepiride patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 52 Baseline and week 52 This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
HbA1c Change From Baseline at Week 104 Baseline and week 104 This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
- Secondary Outcome Measures
Name Time Method HbA1c Change at Week 40 Baseline and week 40 HbA1c Change at Week 52 Baseline and week 52 HbA1c Change at Week 65 Baseline and week 65 HbA1c Change at Week 78 Baseline and week 78 HbA1c Change at Week 91 Baseline and week 91 Incidence of Hypoglycaemic Events up to 104 Weeks Week 104 A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 Baseline and week 52 This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 Baseline and week 104 This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Percentage of Patients With HbA1c <7.0% at Week 52 Week 52 The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Percentage of Patients With HbA1c <7.0% at Week 104 Week 104 The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Percentage of Patients With HbA1c <6.5% at Week 52 Week 52 The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Percentage of Patients With HbA1c <6.5% at Week 104 Week 104 The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 Week 104 Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 Baseline and week 104 This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.
HbA1c Change at Week 4 Baseline and week 4 Difference of base percent value \[Week x(%) - baseline (%)\]
HbA1c Change at Week 8 Baseline and week 8 HbA1c Change at Week 12 Baseline and week 12 HbA1c Change at Week 16 Baseline and week 16 HbA1c Change at Week 28 Baseline and week 28 HbA1c Change at Week 104 Baseline and week 104 The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.
Change in Baseline Lipid Parameter Cholesterol at Week 104 Baseline and week 104 Change in Baseline Lipid Parameter HDL at Week 104 Baseline and week 104 Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 Baseline and week 104 Change in Baseline Lipid Parameter Triglyceride at Week 104 Baseline and week 104 Body Weight Change From Baseline at Week 52 Baseline and week 52 This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Body Weight Change From Baseline at Week 104 Baseline and week 104 This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Incidence of Hypoglycaemic Events up to 52 Weeks Week 52 A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Trial Locations
- Locations (221)
1218.20.10033 Boehringer Ingelheim Investigational Site
🇺🇸Tempe, Arizona, United States
1218.20.10003 Boehringer Ingelheim Investigational Site
🇺🇸Chula Vista, California, United States
1218.20.10020 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.20.10035 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.20.10037 Boehringer Ingelheim Investigational Site
🇺🇸Los Gatos, California, United States
1218.20.10034 Boehringer Ingelheim Investigational Site
🇺🇸West Palm Beach, Florida, United States
1218.20.10023 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
1218.20.10030 Boehringer Ingelheim Investigational Site
🇺🇸Topeka, Kansas, United States
1218.20.10028 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
1218.20.10006 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
Scroll for more (211 remaining)1218.20.10033 Boehringer Ingelheim Investigational Site🇺🇸Tempe, Arizona, United States