Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
- Registration Number
- NCT00601250
- 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 patients with type 2 diabetes mellitus with insufficient glycaemic control
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 701
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linagliptin linagliptin Patients receive linagliptin 5 mg tablets once daily Placebo linagliptin Patients receive placebo tablets matching linagliptin 5 mg tablets 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 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 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 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.
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%. 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 7.0% 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%
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%.
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 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%.
2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24 Baseline and week 24 This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.
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.
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.
Trial Locations
- Locations (82)
1218.17.91002 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.17.91005 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.17.91012 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.17.91014 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.17.91006 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1218.17.97272 Boehringer Ingelheim Investigational Site
🇮🇱Nahariya, Israel
1218.17.91010 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1218.17.52003 Boehringer Ingelheim Investigational Site
🇲🇽Col. Lomas de San Francisco, Monterrey, Mexico
1218.17.91007 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
1218.17.97271 Boehringer Ingelheim Investigational Site
🇮🇱Jerusalem, Israel
1218.17.97278 Boehringer Ingelheim Investigational Site
🇮🇱Tel Aviv, Israel
1218.17.52005 Boehringer Ingelheim Investigational Site
🇲🇽Colonia Reforma Social, Mexico
1218.17.52006 Boehringer Ingelheim Investigational Site
🇲🇽Faccionamiento Lomas de Campestre,AGUASCAL, Mexico
1218.17.70002 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.17.42004 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1218.17.91001 Boehringer Ingelheim Investigational Site
🇮🇳Trivandrum, India
1218.17.97274 Boehringer Ingelheim Investigational Site
🇮🇱Afula, Israel
1218.17.97275 Boehringer Ingelheim Investigational Site
🇮🇱Holon, Israel
1218.17.46015 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1218.17.91008 Boehringer Ingelheim Investigational Site
🇮🇳Mangalore, India
1218.17.91011 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, India
1218.17.91004 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.17.91003 Boehringer Ingelheim Investigational Site
🇮🇳Nasik, India
1218.17.91013 Boehringer Ingelheim Investigational Site
🇮🇳Uttar Pradesh, India
1218.17.97273 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1218.17.46004 Boehringer Ingelheim Investigational Site
🇸🇪Uppsala, Sweden
1218.17.46012 Boehringer Ingelheim Investigational Site
🇸🇪Uddevalla, Sweden
1218.17.10001 Boehringer Ingelheim Investigational Site
🇺🇸Walnut Creek, California, United States
1218.17.10014 Boehringer Ingelheim Investigational Site
🇺🇸Spring Valley, California, United States
1218.17.10003 Boehringer Ingelheim Investigational Site
🇺🇸Chula Vista, California, United States
1218.17.10021 Boehringer Ingelheim Investigational Site
🇺🇸Northglenn, Colorado, United States
1218.17.10017 Boehringer Ingelheim Investigational Site
🇺🇸Gurnee, Illinois, United States
1218.17.10013 Boehringer Ingelheim Investigational Site
🇺🇸Mentor, Ohio, United States
1218.17.10002 Boehringer Ingelheim Investigational Site
🇺🇸Greer, South Carolina, United States
1218.17.10004 Boehringer Ingelheim Investigational Site
🇺🇸Simpsonville, South Carolina, United States
1218.17.42001 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1218.17.42006 Boehringer Ingelheim Investigational Site
🇨🇿Breclav, Czech Republic
1218.17.42007 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1218.17.42009 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1218.17.42008 Boehringer Ingelheim Investigational Site
🇨🇿Hodonin, Czech Republic
1218.17.42003 Boehringer Ingelheim Investigational Site
🇨🇿Olomouc, Czech Republic
1218.17.35806 Boehringer Ingelheim Investigational Site
🇫🇮Helsinki, Finland
1218.17.35801 Boehringer Ingelheim Investigational Site
🇫🇮Kuopio, Finland
1218.17.35803 Boehringer Ingelheim Investigational Site
🇫🇮Oulu, Finland
1218.17.35805 Boehringer Ingelheim Investigational Site
🇫🇮Seinäjoki, Finland
1218.17.35804 Boehringer Ingelheim Investigational Site
🇫🇮Jyväskylä, Finland
1218.17.35802 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1218.17.30004 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1218.17.30013 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1218.17.91009 Boehringer Ingelheim Investigational Site
🇮🇳Andhra Pradesh, India
1218.17.30011 Boehringer Ingelheim Investigational Site
🇬🇷Piraeus, Greece
1218.17.97276 Boehringer Ingelheim Investigational Site
🇮🇱Safed, Israel
1218.17.52007 Boehringer Ingelheim Investigational Site
🇲🇽Aguascalientes, Ags., Mexico
1218.17.52009 Boehringer Ingelheim Investigational Site
🇲🇽cOL OBREGON,León, Guanajuato, Mexico
1218.17.52001 Boehringer Ingelheim Investigational Site
🇲🇽Col. Mitras Centro, Monterrey, N.L., Mexico
1218.17.52002 Boehringer Ingelheim Investigational Site
🇲🇽Mexico, Mexico
1218.17.52008 Boehringer Ingelheim Investigational Site
🇲🇽Colonia Tlalpan, mexico, Mexico
1218.17.52010 Boehringer Ingelheim Investigational Site
🇲🇽Col.Americana, Guadalajara, Jalisco, Mexico
1218.17.52004 Boehringer Ingelheim Investigational Site
🇲🇽Tlalpan-México D,F, Mexico
1218.17.64004 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand
1218.17.64002 Boehringer Ingelheim Investigational Site
🇳🇿Otahuhu, New Zealand
1218.17.64003 Boehringer Ingelheim Investigational Site
🇳🇿Dunedin, New Zealand
1218.17.64001 Boehringer Ingelheim Investigational Site
🇳🇿Tauranga, New Zealand
1218.17.70001 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.17.64005 Boehringer Ingelheim Investigational Site
🇳🇿Wellington, New Zealand
1218.17.70003 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1218.17.70005 Boehringer Ingelheim Investigational Site
🇷🇺Novosibirsk, Russian Federation
1218.17.70006 Boehringer Ingelheim Investigational Site
🇷🇺Perm, Russian Federation
1218.17.46013 Boehringer Ingelheim Investigational Site
🇸🇪Härnösand, Sweden
1218.17.70004 Boehringer Ingelheim Investigational Site
🇷🇺Tomsk, Russian Federation
1218.17.46001 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
1218.17.10009 Boehringer Ingelheim Investigational Site
🇺🇸Federal Way, Washington, United States
1218.17.10016 Boehringer Ingelheim Investigational Site
🇺🇸Eugene, Oregon, United States
1218.17.10012 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
1218.17.10010 Boehringer Ingelheim Investigational Site
🇺🇸Hollywood, Florida, United States
1218.17.10011 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1218.17.10005 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1218.17.10008 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1218.17.10015 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
1218.17.10007 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1218.17.10006 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1218.17.10018 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States