BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
- Registration Number
- NCT00602472
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1058
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo matching linagliptin 5 mg tablets linagliptin 5 mg linagliptin linagliptin 5 mg once daily
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline to Week 24 Baseline and week 24 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
- Secondary Outcome Measures
Name Time Method HbA1c Change From Baseline to Week 6 Baseline and week 6 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline to Week 12 Baseline and week 12 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline to Week 18 Baseline and week 18 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline to Week 24 Baseline and week 24 This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 6 Baseline and week 6 This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 12 Baseline and week 12 This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline to Week 18 Baseline and week 18 This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication
Percentage of Patients With HbA1c <7.0% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c \>= 7%
Percentage of Patients With HbA1c < 7.0% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c \>= 6.5%
Percentage of Patients With HbA1c<6.5% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%
Trial Locations
- Locations (100)
1218.18.32006 Boehringer Ingelheim Investigational Site
🇧🇪Edegem, Belgium
1218.18.32002 Boehringer Ingelheim Investigational Site
🇧🇪Huy, Belgium
1218.18.01003 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1218.18.01007 Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
1218.18.01004 Boehringer Ingelheim Investigational Site
🇨🇦Montague, Prince Edward Island, Canada
1218.18.63001 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Pasig, Philippines
1218.18.63003 Boehringer Ingelheim Investigational Site
🇵ðŸ‡San Juan, Philippines
1218.18.88602 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1218.18.70013 Boehringer Ingelheim Investigational Site
🇷🇺Rostov-on-Don, Russian Federation
1218.18.70016 Boehringer Ingelheim Investigational Site
🇷🇺Samara, Russian Federation
1218.18.88605 Boehringer Ingelheim Investigational Site
🇨🇳Changhua, Taiwan
1218.18.70012 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.18.88606 Boehringer Ingelheim Investigational Site
🇨🇳Tainan, Taiwan
1218.18.88608 Boehringer Ingelheim Investigational Site
🇨🇳Taoyuan, Taiwan
1218.18.88601 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1218.18.88603 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1218.18.88607 Boehringer Ingelheim Investigational Site
🇨🇳Taipei, Taiwan
1218.18.86005 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, Jiangsu Province, China
1218.18.54014 Boehringer Ingelheim Investigational Site
🇦🇷Corrientes, Argentina
1218.18.54011 Boehringer Ingelheim Investigational Site
🇦🇷Mendoza, Argentina
1218.18.54007 Boehringer Ingelheim Investigational Site
🇦🇷Salta, Argentina
1218.18.86013 Boehringer Ingelheim Investigational Site
🇨🇳Chengdu, Sichuan Province, China
1218.18.90003 Boehringer Ingelheim Investigational Site
🇹🇷Erzurum, Turkey
1218.18.49014 Boehringer Ingelheim Investigational Site
🇩🇪Saarbrücken, Germany
1218.18.82008 Boehringer Ingelheim Investigational Site
🇰🇷Incheon, Korea, Republic of
1218.18.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.18.82009 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.18.54012 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1218.18.49028 Boehringer Ingelheim Investigational Site
🇩🇪Bad Mergentheim, Germany
1218.18.01009 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1218.18.32004 Boehringer Ingelheim Investigational Site
🇧🇪Genk, Belgium
1218.18.86015 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1218.18.86010 Boehringer Ingelheim Investigational Site
🇨🇳Shen Yang, China
1218.18.01010 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.18.86004 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1218.18.54010 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.18.54003 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1218.18.54015 Boehringer Ingelheim Investigational Site
🇦🇷Parque Velez Sarfield, Argentina
1218.18.32007 Boehringer Ingelheim Investigational Site
🇧🇪Brussel, Belgium
1218.18.32001 Boehringer Ingelheim Investigational Site
🇧🇪Liège, Belgium
1218.18.86014 Boehringer Ingelheim Investigational Site
🇨🇳Haerbin, China
1218.18.86003 Boehringer Ingelheim Investigational Site
🇨🇳Weizikeng, China
1218.18.01006 Boehringer Ingelheim Investigational Site
🇨🇦Etobicoke, Ontario, Canada
1218.18.49101 Boehringer Ingelheim Investigational Site
🇩🇪Mainz, Germany
1218.18.82004 Boehringer Ingelheim Investigational Site
🇰🇷Busan, Korea, Republic of
1218.18.86007 Boehringer Ingelheim Investigational Site
🇨🇳Wuhan, China
1218.18.86006 Boehringer Ingelheim Investigational Site
🇨🇳Xian, Shanxi Province, China
1218.18.44001 Boehringer Ingelheim Investigational Site
🇬🇧Bath, United Kingdom
1218.18.82006 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.18.82002 Boehringer Ingelheim Investigational Site
🇰🇷Pusan, Korea, Republic of
1218.18.49003 Boehringer Ingelheim Investigational Site
🇩🇪Neuwied, Germany
1218.18.86009 Boehringer Ingelheim Investigational Site
🇨🇳Dalian, China
1218.18.86012 Boehringer Ingelheim Investigational Site
🇨🇳Wuhan, Hubei Province, China
1218.18.90004 Boehringer Ingelheim Investigational Site
🇹🇷Konya, Turkey
1218.18.44004 Boehringer Ingelheim Investigational Site
🇬🇧Baillieston, Glasgow, United Kingdom
1218.18.44010 Boehringer Ingelheim Investigational Site
🇬🇧Bury St Edmonds, United Kingdom
1218.18.49007 Boehringer Ingelheim Investigational Site
🇩🇪Nürnberg, Germany
1218.18.01012 Boehringer Ingelheim Investigational Site
🇨🇦Oakville, Ontario, Canada
1218.18.86002 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1218.18.49022 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1218.18.63002 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Marikina, Philippines
1218.18.90005 Boehringer Ingelheim Investigational Site
🇹🇷Istanbul, Turkey
1218.18.44003 Boehringer Ingelheim Investigational Site
🇬🇧Burbage, United Kingdom
1218.18.49024 Boehringer Ingelheim Investigational Site
🇩🇪Bosenheim, Germany
1218.18.82001 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.18.82003 Boehringer Ingelheim Investigational Site
🇰🇷Suwon, Korea, Republic of
1218.18.90001 Boehringer Ingelheim Investigational Site
🇹🇷Izmir, Turkey
1218.18.44009 Boehringer Ingelheim Investigational Site
🇬🇧Cardiff, United Kingdom
1218.18.44007 Boehringer Ingelheim Investigational Site
🇬🇧Waterloo, Liverpool, United Kingdom
1218.18.44005 Boehringer Ingelheim Investigational Site
🇬🇧Ashford, United Kingdom
1218.18.44002 Boehringer Ingelheim Investigational Site
🇬🇧Penarth, United Kingdom
1218.18.01002 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1218.18.82007 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1218.18.54002 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.18.54001 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.18.54005 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.18.54004 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.18.54013 Boehringer Ingelheim Investigational Site
🇦🇷Córdoba, Argentina
1218.18.54009 Boehringer Ingelheim Investigational Site
🇦🇷Córdoba, Argentina
1218.18.54006 Boehringer Ingelheim Investigational Site
🇦🇷Rosario, Argentina
1218.18.32005 Boehringer Ingelheim Investigational Site
🇧🇪Brugge, Belgium
1218.18.32003 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1218.18.01005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.18.01001 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1218.18.01011 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1218.18.01008 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1218.18.86001 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1218.18.86011 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1218.18.86008 Boehringer Ingelheim Investigational Site
🇨🇳Qingdao, China
1218.18.49004 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1218.18.49020 Boehringer Ingelheim Investigational Site
🇩🇪Dresden, Germany
1218.18.82010 Boehringer Ingelheim Investigational Site
🇰🇷Jeonju, Korea, Republic of
1218.18.82011 Boehringer Ingelheim Investigational Site
🇰🇷Daegu, Korea, Republic of
1218.18.63005 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Manila, Philippines
1218.18.63004 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Quezon City, Philippines
1218.18.70014 Boehringer Ingelheim Investigational Site
🇷🇺Arkhangelsk, Russian Federation
1218.18.70015 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.18.88604 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1218.18.44008 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1218.18.44006 Boehringer Ingelheim Investigational Site
🇬🇧Reading, United Kingdom