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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001569-27 | EudraCT Number | EudraCT |
Not provided
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to determine safety, efficacy and tolerability of BI 1356 versus placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1356 | Experimental | patient to receive a tablet containing BI 1356 once daily |
|
| placebo | Placebo Comparator | patient to receive a tablet identical to BI 1356 once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1356 | Drug | BI 1356 dosed once daily |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at 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. | Baseline and Week 52 |
Not provided
Inclusion criteria:
Exclusion criteria:
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.43.10027 Boehringer Ingelheim Investigational Site | Phoenix | Arizona | United States | |||
| 1218.43.10011 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24169807 | Derived | McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| FG001 | Linagliptin (BI 1356) | Patients randomized to receive treatment with Linagliptin 5mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
placebo matching BI 1356 taken once daily |
|
| HbA1c Change From Baseline at 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. |
| Baseline and Week 18 |
| HbA1c Change From Baseline at 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. | Baseline and Week 24 |
| HbA1c Change From Baseline at 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. | Baseline and Week 30 |
| HbA1c Change From Baseline at 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. | Baseline and Week 36 |
| HbA1c Change From Baseline at 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. | Baseline and Week 42 |
| HbA1c Change From Baseline at 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. | Baseline and Week 48 |
| The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment | 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% | Baseline and Week 52 |
| The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment | 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%. | Baseline and Week 52 |
| Percentage of Patients With HbA1c Lowering by 0.5% at 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). | Baseline and Week 52 |
| FPG Change From Baseline at 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 | Baseline and Week 12 |
| FPG Change From Baseline at Week 18 | Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs | Baseline and Week 18 |
| FPG Change From Baseline at 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 | Baseline and Week 24 |
| FPG Change From Baseline at 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 | Baseline and Week 30 |
| FPG Change From Baseline at 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 | Baseline and Week 36 |
| FPG Change From Baseline at 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 | Baseline and Week 42 |
| FPG Change From Baseline at 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 | Baseline and Week 48 |
| FPG Change From Baseline at week52 | 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 | Baseline and Week 52 |
| Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin. | Baseline and Week 52 |
| Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | 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. | first administration of randomised treatment to .... |
| Chula Vista |
| California |
| United States |
| 1218.43.10006 Boehringer Ingelheim Investigational Site | Riverside | California | United States |
| 1218.43.10021 Boehringer Ingelheim Investigational Site | Whittier | California | United States |
| 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 |
| 1218.43.10015 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | United States |
| 1218.43.10016 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States |
| 1218.43.10003 Boehringer Ingelheim Investigational Site | Great Neck | New York | United States |
| 1218.43.10004 Boehringer Ingelheim Investigational Site | The Bronx | New York | United States |
| 1218.43.10020 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States |
| 1218.43.10019 Boehringer Ingelheim Investigational Site | Delaware | Ohio | United States |
| 1218.43.10008 Boehringer Ingelheim Investigational Site | Mentor | Ohio | United States |
| 1218.43.10005 Boehringer Ingelheim Investigational Site | Bethlehem | Pennsylvania | United States |
| 1218.43.10007 Boehringer Ingelheim Investigational Site | Carlisle | Pennsylvania | United States |
| 1218.43.10001 Boehringer Ingelheim Investigational Site | Providence | Rhode Island | United States |
| 1218.43.10025 Boehringer Ingelheim Investigational Site | Aiken | South Carolina | United States |
| 1218.43.10023 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
| 1218.43.10024 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
| 1218.43.10014 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.43.10017 Boehringer Ingelheim Investigational Site | Lufkin | Texas | United States |
| 1218.43.10010 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| 1218.43.61009 Boehringer Ingelheim Investigational Site | Gosford | New South Wales | Australia |
| 1218.43.61010 Boehringer Ingelheim Investigational Site | Auchenflower | Queensland | Australia |
| 1218.43.61006 Boehringer Ingelheim Investigational Site | Kippa-Ring | Queensland | Australia |
| 1218.43.61007 Boehringer Ingelheim Investigational Site | Reservoir | Victoria | Australia |
| 1218.43.61011 Boehringer Ingelheim Investigational Site | Richmond | Victoria | Australia |
| 1218.43.61005 Boehringer Ingelheim Investigational Site | Adelaide, SA | Australia |
| 1218.43.61002 Boehringer Ingelheim Investigational Site | Herston, QLD | Australia |
| 1218.43.85201 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong |
| 1218.43.85203 Boehringer Ingelheim Investigational Site | New Territories | Hong Kong |
| 1218.43.97008 Boehringer Ingelheim Investigational Site | Afula | Israel |
| 1218.43.97005 Boehringer Ingelheim Investigational Site | Ashkelon | Israel |
| 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 |
| 1218.43.97002 Boehringer Ingelheim Investigational Site | Kfar Saba | Israel |
| 1218.43.97007 Boehringer Ingelheim Investigational Site | Nahariya | Israel |
| 1218.43.97001 Boehringer Ingelheim Investigational Site | Safed | Israel |
| 1218.43.97006 Boehringer Ingelheim Investigational Site | Tel Aviv | Israel |
| 1218.43.64001 Boehringer Ingelheim Investigational Site | Auckland | New Zealand |
| 1218.43.64003 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 1218.43.64004 Boehringer Ingelheim Investigational Site | Takpuna | New Zealand |
| 1218.43.64002 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand |
| 1218.43.38003 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.43.38004 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.43.38006 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.43.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.43.38007 Boehringer Ingelheim Investigational Site | Luhansk | Ukraine |
| 1218.43.38008 Boehringer Ingelheim Investigational Site | Ternopil | Ukraine |
| 1218.43.38002 Boehringer Ingelheim Investigational Site | Zaporizhzhya | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| BG001 | Linagliptin (BI 1356) | Patients randomized to receive treatment with Linagliptin 5mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin (HbA1c) at baseline | Described in the patients of the Full Analysis Set : 62 in placebo group versus 66 in Linagliptin group | Mean | Standard Deviation | percentage |
| ||||||||||||||
| Fasting plasma glucose (FPG) at baseline | Described in the patients of the Full Analysis Set : 62 in placebo group versus 66 in Linagliptin group | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Body Mass Index (BMI) Continuous | Mean | Standard Deviation | kg/m² |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 12 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 52 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 18 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 24 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 30 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 36 |
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| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 42 |
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| Secondary | HbA1c Change From Baseline at 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 Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and Week 48 |
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| Secondary | The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment | 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% | This population includes the FAS with baseline HbA1c>=6.5%. Non-completers were considered as failure imputation (NCF). | Posted | Number | Percentage of patients | Baseline and Week 52 |
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| Secondary | The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment | 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%. | This population includes the FAS with baseline HbA1c>=7.0%. Non-completers were considered as failure imputation (NCF). | Posted | Number | Percentage of patients | Baseline and Week 52 |
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| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% at 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). | The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF). | Posted | Number | Percentage of patients | Baseline and Week 52 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 12 |
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| Secondary | FPG Change From Baseline at Week 18 | Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 18 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 24 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 30 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 36 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 42 |
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| Secondary | FPG Change From Baseline at 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 48 |
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| Secondary | FPG Change From Baseline at week52 | 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 | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 52 |
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| Secondary | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin. | Treated Set | Posted | Number | Participants | Baseline and Week 52 |
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| Secondary | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | 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. | Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG | Posted | Number | participants | first administration of randomised treatment to .... |
|
|
52 weeks
The period of 52 weeks was the maximum of study treatment. Patients were allowed to remain on study medication for up to 52 weeks.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients randomized to receive treatment with matching placebo | 27 | 65 | 50 | 65 | ||
| EG001 | Linagliptin (BI 1356) | Patients randomized to receive treatment with Linagliptin 5mg | 25 | 68 | 61 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Parathyroid gland enlargement | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac death | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary hilar enlargement | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
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