Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: BI 1356Drug: placebo
- Registration Number
- NCT00800683
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 133
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1356 BI 1356 patient to receive a tablet containing BI 1356 once daily placebo placebo patient to receive a tablet identical to BI 1356 once daily
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 12 Baseline and Week 12 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
- Secondary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 52 Baseline and Week 52 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 18 Baseline and Week 18 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 24 Baseline and Week 24 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 30 Baseline and Week 30 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 36 Baseline and Week 36 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 42 Baseline and Week 42 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 48 Baseline and Week 48 HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment Baseline and Week 52 The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5%
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment Baseline and Week 52 The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 Baseline and Week 52 The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
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 continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 18 Baseline and Week 18 Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
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 continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 30 Baseline and Week 30 This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 36 Baseline and Week 36 This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 42 Baseline and Week 42 This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at Week 48 Baseline and Week 48 This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
FPG Change From Baseline at week52 Baseline and Week 52 This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time Baseline and Week 52 Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG first administration of randomised treatment to .... Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Trial Locations
- Locations (53)
1218.43.10013 Boehringer Ingelheim Investigational Site
🇺🇸Pembroke Pines, Florida, United States
1218.43.10009 Boehringer Ingelheim Investigational Site
🇺🇸West Palm Beach, Florida, United States
1218.43.10018 Boehringer Ingelheim Investigational Site
🇺🇸Decatur, Georgia, United States
1218.43.10022 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1218.43.10005 Boehringer Ingelheim Investigational Site
🇺🇸Bethlehem, Pennsylvania, United States
1218.43.10007 Boehringer Ingelheim Investigational Site
🇺🇸Carlisle, Pennsylvania, United States
1218.43.61002 Boehringer Ingelheim Investigational Site
🇦🇺Herston, QLD, Australia
1218.43.10016 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Missouri, United States
1218.43.10020 Boehringer Ingelheim Investigational Site
🇺🇸Winston-Salem, North Carolina, United States
1218.43.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1218.43.38005 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1218.43.10015 Boehringer Ingelheim Investigational Site
🇺🇸Shreveport, Louisiana, United States
1218.43.10014 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1218.43.10004 Boehringer Ingelheim Investigational Site
🇺🇸Bronx, New York, United States
1218.43.61005 Boehringer Ingelheim Investigational Site
🇦🇺Adelaide, SA, Australia
1218.43.97005 Boehringer Ingelheim Investigational Site
🇮🇱Ashkelon, Israel
1218.43.61009 Boehringer Ingelheim Investigational Site
🇦🇺Gosford, New South Wales, Australia
1218.43.64003 Boehringer Ingelheim Investigational Site
🇳🇿Christchurch, New Zealand
1218.43.10006 Boehringer Ingelheim Investigational Site
🇺🇸Riverside, California, United States
1218.43.10003 Boehringer Ingelheim Investigational Site
🇺🇸Great Neck, New York, United States
1218.43.10025 Boehringer Ingelheim Investigational Site
🇺🇸Aiken, South Carolina, United States
1218.43.10024 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1218.43.61010 Boehringer Ingelheim Investigational Site
🇦🇺Auchenflower, Queensland, Australia
1218.43.38002 Boehringer Ingelheim Investigational Site
🇺🇦Zaporizhzhya, Ukraine
1218.43.64004 Boehringer Ingelheim Investigational Site
🇳🇿Takpuna, New Zealand
1218.43.61006 Boehringer Ingelheim Investigational Site
🇦🇺Kippa Ring, Queensland, Australia
1218.43.10008 Boehringer Ingelheim Investigational Site
🇺🇸Mentor, Ohio, United States
1218.43.10001 Boehringer Ingelheim Investigational Site
🇺🇸Providence, Rhode Island, United States
1218.43.61011 Boehringer Ingelheim Investigational Site
🇦🇺Richmond, Victoria, Australia
1218.43.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1218.43.38006 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1218.43.38007 Boehringer Ingelheim Investigational Site
🇺🇦Lugansk, Ukraine
1218.43.64001 Boehringer Ingelheim Investigational Site
🇳🇿Auckland, New Zealand
1218.43.64002 Boehringer Ingelheim Investigational Site
🇳🇿Tauranga, New Zealand
1218.43.38008 Boehringer Ingelheim Investigational Site
🇺🇦Ternopil, Ukraine
1218.43.97007 Boehringer Ingelheim Investigational Site
🇮🇱Nahariya, Israel
1218.43.97008 Boehringer Ingelheim Investigational Site
🇮🇱Afula, Israel
1218.43.10027 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1218.43.97003 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1218.43.97004 Boehringer Ingelheim Investigational Site
🇮🇱Jerusalem, Israel
1218.43.97009 Boehringer Ingelheim Investigational Site
🇮🇱Jerusalem, Israel
1218.43.10011 Boehringer Ingelheim Investigational Site
🇺🇸Chula Vista, California, United States
1218.43.10021 Boehringer Ingelheim Investigational Site
🇺🇸Whittier, California, United States
1218.43.97002 Boehringer Ingelheim Investigational Site
🇮🇱Kfar Saba, Israel
1218.43.97006 Boehringer Ingelheim Investigational Site
🇮🇱Tel Aviv, Israel
1218.43.97001 Boehringer Ingelheim Investigational Site
🇮🇱Safed, Israel
1218.43.61007 Boehringer Ingelheim Investigational Site
🇦🇺Reservoir, Victoria, Australia
1218.43.10023 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1218.43.10019 Boehringer Ingelheim Investigational Site
🇺🇸Delaware, Ohio, United States
1218.43.10017 Boehringer Ingelheim Investigational Site
🇺🇸Lufkin, Texas, United States
1218.43.10010 Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
1218.43.85201 Boehringer Ingelheim Investigational Site
🇭🇰Hong Kong, Hong Kong
1218.43.85203 Boehringer Ingelheim Investigational Site
🇭🇰New Territories, Hong Kong