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
- 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)
1218.35.91007 Boehringer Ingelheim Investigational Site
🇮🇳Aminjikarai, Tamilnadu, India
1218.35.91001 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, Karnataka, India
1218.35.91004 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, Karnataka, India
1218.35.91002 Boehringer Ingelheim Investigational Site
🇮🇳Indore, India
1218.35.91008 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, Maharastra, India
1218.35.91005 Boehringer Ingelheim Investigational Site
🇮🇳Nagpur, Maharashtra, India
1218.35.91006 Boehringer Ingelheim Investigational Site
🇮🇳Pune, Maharastra, India
1218.35.81003 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1218.35.81001 Boehringer Ingelheim Investigational Site
🇯🇵Shinjyuku-ku,Tokyo, Japan
1218.35.81002 Boehringer Ingelheim Investigational Site
🇯🇵Suita, Osaka,, Japan
Scroll for more (35 remaining)1218.35.91007 Boehringer Ingelheim Investigational Site🇮🇳Aminjikarai, Tamilnadu, India