Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002448-10 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin 5 mg | Experimental | linagliptin 5 mg once daily |
|
| placebo | Placebo Comparator | placebo matching linagliptin 5 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin | Drug | active |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at 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. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at 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. | Baseline and week 6 |
| HbA1c Change From Baseline at Week 12 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.16.38605 Boehringer Ingelheim Investigational Site | Krapinske Toplice | Croatia | ||||
| 1218.16.38604 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27484756 | Derived | Del Prato S, Patel S, Crowe S, von Eynatten M. Efficacy and safety of linagliptin according to patient baseline characteristics: A pooled analysis of three phase 3 trials. Nutr Metab Cardiovasc Dis. 2016 Oct;26(10):886-92. doi: 10.1016/j.numecd.2016.06.015. Epub 2016 Jul 1. | |
| 22234149 | Derived | Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3. |
Not provided
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Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| FG001 | Linagliptin | Patients randomized to receive treatment with Linagliptin 5mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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| Drug |
placebo |
|
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. |
| Baseline and week 12 |
| HbA1c Change From Baseline at 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. | 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 baseline HbA1c, baseline FPG and previous anti-diabetic medication. | Baseline and week 24 |
| FPG Change From Baseline at 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. | Baseline and week 6 |
| 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 baseline HbA1c, baseline FPG and previous anti-diabetic medication. | Baseline and week 12 |
| FPG Change From Baseline at 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. | Baseline and week 18 |
| Percentage of Patients With HbA1c <7.0% at 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% | Baseline and week 24 |
| Percentage of Patients With HbA1c<7.0% at 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%. | Baseline and week 24 |
| Percentage of Patients With HbA1c <6.5% at 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%. | Baseline and week 24 |
| Percentage of Patients With HbA1c<6.5% at 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%. | Baseline and week 24 |
| Percentage of Patients With HbA1c Lowering by 0.5% at 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%. | Baseline and week 24 |
| Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at 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. | Baseline and week 24 |
| Slavonski Brod |
| Croatia |
| 1218.16.91009 Boehringer Ingelheim Investigational Site | Andhra Pradesh | India |
| 1218.16.91002 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.16.91005 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.16.91014 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1218.16.91013 Boehringer Ingelheim Investigational Site | Ghaziabad | India |
| 1218.16.91010 Boehringer Ingelheim Investigational Site | Hyderabad | India |
| 1218.16.91006 Boehringer Ingelheim Investigational Site | Jaipur | India |
| 1218.16.91011 Boehringer Ingelheim Investigational Site | Maharashtra | India |
| 1218.16.91008 Boehringer Ingelheim Investigational Site | Mangalore | India |
| 1218.16.91007 Boehringer Ingelheim Investigational Site | Manipal | India |
| 1218.16.91004 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1218.16.91003 Boehringer Ingelheim Investigational Site | Nashik | India |
| 1218.16.91012 Boehringer Ingelheim Investigational Site | Tamilnadu | India |
| 1218.16.91001 Boehringer Ingelheim Investigational Site | Trivandrum, Kerala | India |
| 1218.16.97267 Boehringer Ingelheim Investigational Site | Giv‘atayim | Israel |
| 1218.16.97263 Boehringer Ingelheim Investigational Site | Haifa | Israel |
| 1218.16.97265 Boehringer Ingelheim Investigational Site | Holon | Israel |
| 1218.16.97261 Boehringer Ingelheim Investigational Site | Jerusalem | Israel |
| 1218.16.97262 Boehringer Ingelheim Investigational Site | Nahariya | Israel |
| 1218.16.97266 Boehringer Ingelheim Investigational Site | Safed | Israel |
| 1218.16.39004 Boehringer Ingelheim Investigational Site | Catanzaro | Italy |
| 1218.16.39008 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1218.16.39002 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1218.16.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1218.16.39006 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1218.16.60006 Boehringer Ingelheim Investigational Site | Alor Star | Malaysia |
| 1218.16.60003 Boehringer Ingelheim Investigational Site | Kelantan Kota Bahru | Malaysia |
| 1218.16.60001 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1218.16.60002 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1218.16.60004 Boehringer Ingelheim Investigational Site | Perak | Malaysia |
| 1218.16.60005 Boehringer Ingelheim Investigational Site | Perak | Malaysia |
| 1218.16.60007 Boehringer Ingelheim Investigational Site | Pulau Pinang | Malaysia |
| 1218.16.31009 Boehringer Ingelheim Investigational Site | Andijk | Netherlands |
| 1218.16.31024 Boehringer Ingelheim Investigational Site | Castricum | Netherlands |
| 1218.16.31006 Boehringer Ingelheim Investigational Site | Deurne | Netherlands |
| 1218.16.31001 Boehringer Ingelheim Investigational Site | Ewijk | Netherlands |
| 1218.16.31010 Boehringer Ingelheim Investigational Site | Losser | Netherlands |
| 1218.16.31003 Boehringer Ingelheim Investigational Site | Oude Pekela | Netherlands |
| 1218.16.31021 Boehringer Ingelheim Investigational Site | Poortvliet | Netherlands |
| 1218.16.31004 Boehringer Ingelheim Investigational Site | Rijswijk | Netherlands |
| 1218.16.31008 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands |
| 1218.16.31002 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands |
| 1218.16.48603 Boehringer Ingelheim Investigational Site | Lublin | Poland |
| 1218.16.48601 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1218.16.48604 Boehringer Ingelheim Investigational Site | Zabrze | Poland |
| 1218.16.40604 Boehringer Ingelheim Investigational Site | Brasov | Romania |
| 1218.16.40603 Boehringer Ingelheim Investigational Site | Galati | Romania |
| 1218.16.42103 Boehringer Ingelheim Investigational Site | Banská Bystrica | Slovakia |
| 1218.16.42102 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.16.42104 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.16.42105 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.16.42101 Boehringer Ingelheim Investigational Site | Nové Mesto nad Váhom | Slovakia |
| 1218.16.42106 Boehringer Ingelheim Investigational Site | Šamorín | Slovakia |
| 1218.16.66001 Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| 1218.16.66002 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand |
| 1218.16.38011 Boehringer Ingelheim Investigational Site | Dnipro | Ukraine |
| 1218.16.38002 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.16.38004 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.16.38010 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.16.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.16.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.16.38008 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.16.38009 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.16.38012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.16.38003 Boehringer Ingelheim Investigational Site | Lviv | Ukraine |
| 1218.16.38006 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine |
| 1218.16.38007 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 | 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 |
| ||||||||||||||||
| Body Mass Index (BMI) continuous | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Glycosylated Hemoglobin A1 (HbA1C) | Mean | Standard Deviation | Percent |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| 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 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. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline at 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. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | Percent | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 baseline HbA1c, baseline FPG and previous anti-diabetic medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 24 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline at 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. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 6 |
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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 baseline HbA1c, baseline FPG and previous anti-diabetic medication. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG Change From Baseline at 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. | This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value. | Posted | Mean | Standard Error | mg/dL | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <7.0% at 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% | 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 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c<7.0% at 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%. | This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of patients | Baseline and week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <6.5% at 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%. | 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 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c<6.5% at 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%. | This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF). | Posted | Number | Percentage of Patients | Baseline and week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% at 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%. | 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 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at 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. | Meal Tolerance Test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period) | Posted | Mean | Standard Error | mg/dL | Baseline and week 24 |
|
|
From day of first drug dose until 7 days after last dose, an average of 167 days
Not provided
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 | 7 | 167 | 38 | 167 | ||
| EG001 | Linagliptin | Patients randomized to receive treatment with Linagliptin 5mg | 10 | 336 | 29 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cellulitis pharyngeal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
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
| Male |
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