Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: PlaceboDrug: BI 1356
- Registration Number
- NCT00819091
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo one tablet once daily BI 1356 BI 1356 5 mg orally (po) once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 Baseline, week 18 HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose at Week 18 Baseline, week 18 Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Change From Baseline in Fasting Plasma Glucose at Week 12 Baseline, week 12 Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 week 18 An absolute efficacy response is defined as HbA1c \< 7.0% at 18 weeks. A non-response is defined as HbA1c \>= 7.0% at 18 weeks.
Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 week 18 An absolute efficacy response is defined as HbA1c \< 6.5% at 18 weeks. A non-response is defined as HbA1c \>= 6.5% at 18 weeks.
Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 Baseline, week 18 An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 Baseline, week 6 HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 Baseline, week 12 HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 Baseline, week 18 HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
Change From Baseline in Fasting Plasma Glucose at Week 6 Baseline, week 6 Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.
Trial Locations
- Locations (45)
1218.35.91003 Boehringer Ingelheim Investigational Site
🇮🇳Aligarh, Uttar Pradesh, India
1218.35.91006 Boehringer Ingelheim Investigational Site
🇮🇳Pune, Maharastra, India
1218.35.48003 Boehringer Ingelheim Investigational Site
🇵🇱Poznan, Poland
1218.35.48005 Boehringer Ingelheim Investigational Site
🇵🇱Wroclaw, Poland
1218.35.48001 Boehringer Ingelheim Investigational Site
🇵🇱Rzeszow, Poland
1218.35.91008 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, Maharastra, India
1218.35.91004 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, Karnataka, India
1218.35.10001 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.35.10015 Boehringer Ingelheim Investigational Site
🇺🇸Flint, Michigan, United States
1218.35.10019 Boehringer Ingelheim Investigational Site
🇺🇸Sugar Land, Texas, United States
1218.35.81001 Boehringer Ingelheim Investigational Site
🇯🇵Shinjyuku-ku,Tokyo, Japan
1218.35.81002 Boehringer Ingelheim Investigational Site
🇯🇵Suita, Osaka,, Japan
1218.35.81003 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1218.35.70003 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.35.10017 Boehringer Ingelheim Investigational Site
🇺🇸Ft. Lauderdale, Florida, United States
1218.35.70009 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.35.10013 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1218.35.10009 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1218.35.54006 Boehringer Ingelheim Investigational Site
🇦🇷Parque Velez Sarfield, Argentina
1218.35.70007 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1218.35.10018 Boehringer Ingelheim Investigational Site
🇺🇸Asheville, North Carolina, United States
1218.35.91002 Boehringer Ingelheim Investigational Site
🇮🇳Indore, India
1218.35.70008 Boehringer Ingelheim Investigational Site
🇷🇺Arkhangelsk, Russian Federation
1218.35.70001 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.35.70002 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.35.70006 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.35.10016 Boehringer Ingelheim Investigational Site
🇺🇸National City, California, United States
1218.35.10021 Boehringer Ingelheim Investigational Site
🇺🇸Ft. Lauderdale, Florida, United States
1218.35.10004 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
1218.35.54003 Boehringer Ingelheim Investigational Site
🇦🇷Capital Federal, Argentina
1218.35.54005 Boehringer Ingelheim Investigational Site
🇦🇷Corrientes, Argentina
1218.35.54001 Boehringer Ingelheim Investigational Site
🇦🇷Mar del Plata, Argentina
1218.35.36001 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.35.36005 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.35.36003 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºDebrecen, Hungary
1218.35.36002 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.35.36004 Boehringer Ingelheim Investigational Site
ðŸ‡ðŸ‡ºBudapest, Hungary
1218.35.10020 Boehringer Ingelheim Investigational Site
🇺🇸Greenville, South Carolina, United States
1218.35.48004 Boehringer Ingelheim Investigational Site
🇵🇱Lublin, Poland
1218.35.91007 Boehringer Ingelheim Investigational Site
🇮🇳Aminjikarai, Tamilnadu, India
1218.35.91001 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, Karnataka, India
1218.35.91005 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, Maharashtra, India
1218.35.48002 Boehringer Ingelheim Investigational Site
🇵🇱Bialystok, Poland
1218.35.10002 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
1218.35.10005 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States