Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
- Registration Number
- NCT00621140
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 503
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 at 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 at 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 at 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.
FPG Change From Baseline at 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 at 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.
Percentage of Patients With HbA1c <7.0% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c value below 7.0% 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 \>= 7.0%. Only patients with baseline HbA1c \>= 7%
FPG Change From Baseline at 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.
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 \>= 6.5%.
HbA1c Change From Baseline at 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 at Week 18 Baseline and week 18 This change from baseline reflects the Week 18 FPG minus the baseline 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 7.0% 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 \>= 7.0%.
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 \>= 6.5%. Only patients with baseline HbA1c \>= 6.5%.
Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24 Baseline and week 24 This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c reduction from baseline \>= 0.5% 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 reduction less than 0.5%.
Trial Locations
- Locations (69)
1218.16.39004 Boehringer Ingelheim Investigational Site
🇮🇹Catanzaro, Italy
1218.16.39008 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1218.16.39001 Boehringer Ingelheim Investigational Site
🇮🇹Pisa, Italy
1218.16.39006 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1218.16.38003 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine
1218.16.91009 Boehringer Ingelheim Investigational Site
🇮🇳Andhra Pradesh, India
1218.16.91012 Boehringer Ingelheim Investigational Site
🇮🇳Tamilnadu, India
1218.16.97261 Boehringer Ingelheim Investigational Site
🇮🇱Jerusalem, Israel
1218.16.48603 Boehringer Ingelheim Investigational Site
🇵🇱Lublin, Poland
1218.16.48604 Boehringer Ingelheim Investigational Site
🇵🇱Zabrze, Poland
1218.16.42102 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1218.16.40604 Boehringer Ingelheim Investigational Site
🇷🇴Brasov, Romania
1218.16.66002 Boehringer Ingelheim Investigational Site
🇹🇭Khon Kaen, Thailand
1218.16.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1218.16.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.16.38012 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.16.38006 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine
1218.16.60003 Boehringer Ingelheim Investigational Site
🇲🇾Kelantan Kota Bahru, Malaysia
1218.16.60006 Boehringer Ingelheim Investigational Site
🇲🇾Alor Star, Malaysia
1218.16.39002 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1218.16.31003 Boehringer Ingelheim Investigational Site
🇳🇱Oude Pekela, Netherlands
1218.16.31008 Boehringer Ingelheim Investigational Site
🇳🇱Roelofarendsveen, Netherlands
1218.16.40603 Boehringer Ingelheim Investigational Site
🇷🇴Galati, Romania
1218.16.42106 Boehringer Ingelheim Investigational Site
🇸🇰Samorin, Slovakia
1218.16.91005 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.16.91011 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1218.16.97263 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1218.16.97266 Boehringer Ingelheim Investigational Site
🇮🇱Safed, Israel
1218.16.60005 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1218.16.31021 Boehringer Ingelheim Investigational Site
🇳🇱Poortvliet, Netherlands
1218.16.31004 Boehringer Ingelheim Investigational Site
🇳🇱Rijswijk, Netherlands
1218.16.48601 Boehringer Ingelheim Investigational Site
🇵🇱Warsaw, Poland
1218.16.91013 Boehringer Ingelheim Investigational Site
🇮🇳Ghaziabad, India
1218.16.91001 Boehringer Ingelheim Investigational Site
🇮🇳Trivandrum, Kerala, India
1218.16.97265 Boehringer Ingelheim Investigational Site
🇮🇱Holon, Israel
1218.16.60001 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1218.16.31006 Boehringer Ingelheim Investigational Site
🇳🇱Deurne, Netherlands
1218.16.31001 Boehringer Ingelheim Investigational Site
🇳🇱Ewijk, Netherlands
1218.16.31002 Boehringer Ingelheim Investigational Site
🇳🇱Wildervank, Netherlands
1218.16.38605 Boehringer Ingelheim Investigational Site
🇭🇷Krapinske Toplice, Croatia
1218.16.38604 Boehringer Ingelheim Investigational Site
🇭🇷Slavonski Brod, Croatia
1218.16.91002 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.16.91008 Boehringer Ingelheim Investigational Site
🇮🇳Mangalore, India
1218.16.91004 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.16.91003 Boehringer Ingelheim Investigational Site
🇮🇳Nasik, India
1218.16.97262 Boehringer Ingelheim Investigational Site
🇮🇱Nahariya, Israel
1218.16.60002 Boehringer Ingelheim Investigational Site
🇲🇾Kuala Lumpur, Malaysia
1218.16.31024 Boehringer Ingelheim Investigational Site
🇳🇱Castricum, Netherlands
1218.16.31010 Boehringer Ingelheim Investigational Site
🇳🇱Losser, Netherlands
1218.16.42103 Boehringer Ingelheim Investigational Site
🇸🇰Banska Bystrica, Slovakia
1218.16.42105 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1218.16.38010 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1218.16.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.16.38007 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine
1218.16.91014 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.16.91010 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1218.16.91006 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1218.16.91007 Boehringer Ingelheim Investigational Site
🇮🇳Manipal, India
1218.16.97267 Boehringer Ingelheim Investigational Site
🇮🇱Givataim, Israel
1218.16.60004 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1218.16.60007 Boehringer Ingelheim Investigational Site
🇲🇾Pulau Pinang, Malaysia
1218.16.31009 Boehringer Ingelheim Investigational Site
🇳🇱Andijk, Netherlands
1218.16.42104 Boehringer Ingelheim Investigational Site
🇸🇰Bratislava, Slovakia
1218.16.42101 Boehringer Ingelheim Investigational Site
🇸🇰Nove Mesto nad Vahom, Slovakia
1218.16.38011 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1218.16.38002 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1218.16.38008 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.16.38009 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.16.66001 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand