Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016971-31 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Experimental | 52 weeks treatment |
|
| Placebo | Placebo Comparator | First 12 weeks of treatment |
|
| Glimepiride | Active Comparator | Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride | Drug | 1-4 mg daily after 12 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline to 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, renal function impairment and prior use of antidiabetic agents. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline Over Time | HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling. | Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
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 |
|---|---|---|---|---|---|---|
| 1218.64.10007 Boehringer Ingelheim Investigational Site | Chula Vista | California | United States | |||
| 1218.64.10018 Boehringer Ingelheim Investigational Site |
241 patients were randomised to treatment with linagliptin 5mg (n=118) or placebo/glimepiride (n=123). All randomised patients were treated. For the final analysis, one study site was excluded due to serious non-compliance resulting in 122 patients in the placebo/glimepiride group and 113 patients in the linagliptin group.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Glimepiride | Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks. |
| FG001 | Linagliptin 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Up to Interim Analysis (Week 12) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily |
|
| Placebo | Drug | Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment |
|
| Placebo | Drug | Placebo mach to 5 mg linagliptin once daily after 12 weeks |
|
| Linagliptin | Drug | 5 mg once daily |
|
| Fasting Plasma Glucose (FPG) Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | Baseline and week 12 |
| Fasting Plasma Glucose (FPG) Change From Baseline Over Time | This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling. | Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52 |
| Percentage of Patients With HbA1c <7.0% | The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%. | Baseline, week 12 and week 52 |
| Percentage of Patients With HbA1c <6.5% | The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%. | Baseline, week 12 and week 52 |
| Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% | The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%. | Baseline, week 12 and week 52 |
| Plasma Concentration of Linagliptin at Trough | Trough levels of concentration of Linagliptin in plasma. | Week 12, 24 and 52 |
| Pembroke Pines |
| Florida |
| United States |
| 1218.64.10016 Boehringer Ingelheim Investigational Site | Decatur | Georgia | United States |
| 1218.64.10015 Boehringer Ingelheim Investigational Site | Boise | Idaho | United States |
| 1218.64.10002 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1218.64.10004 Boehringer Ingelheim Investigational Site | Flint | Michigan | United States |
| 1218.64.10006 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States |
| 1218.64.10003 Boehringer Ingelheim Investigational Site | The Bronx | New York | United States |
| 1218.64.10013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1218.64.10020 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1218.64.10008 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 1218.64.10009 Boehringer Ingelheim Investigational Site | Arlington | Texas | United States |
| 1218.64.10005 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.64.10011 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1218.64.10014 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1218.64.10010 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| 1218.64.61005 Boehringer Ingelheim Investigational Site | Gosford | New South Wales | Australia |
| 1218.64.61001 Boehringer Ingelheim Investigational Site | Liverpool | New South Wales | Australia |
| 1218.64.61002 Boehringer Ingelheim Investigational Site | St Leonards | New South Wales | Australia |
| 1218.64.61003 Boehringer Ingelheim Investigational Site | Adelaide | South Australia | Australia |
| 1218.64.61004 Boehringer Ingelheim Investigational Site | Reservoir | Victoria | Australia |
| 1218.64.20008 Boehringer Ingelheim Investigational Site | Corunna | Ontario | Canada |
| 1218.64.20005 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1218.64.20007 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1218.64.20002 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.64.20009 Boehringer Ingelheim Investigational Site | Stayner | Ontario | Canada |
| 1218.64.20004 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.64.20003 Boehringer Ingelheim Investigational Site | Point Claire | Quebec | Canada |
| 1218.64.35804 Boehringer Ingelheim Investigational Site | Kokkola | Finland |
| 1218.64.35803 Boehringer Ingelheim Investigational Site | Oulu | Finland |
| 1218.64.35801 Boehringer Ingelheim Investigational Site | Turku | Finland |
| 1218.64.97204 Boehringer Ingelheim Investigational Site | Ashkelon | Israel |
| 1218.64.97207 Boehringer Ingelheim Investigational Site | Giv‘atayim | Israel |
| 1218.64.97203 Boehringer Ingelheim Investigational Site | Haifa | Israel |
| 1218.64.97201 Boehringer Ingelheim Investigational Site | Jerusalem | Israel |
| 1218.64.97202 Boehringer Ingelheim Investigational Site | Nahariya | Israel |
| 1218.64.97206 Boehringer Ingelheim Investigational Site | Tel Aviv | Israel |
| 1218.64.81005 Boehringer Ingelheim Investigational Site | Asahi, Chiba | Japan |
| 1218.64.81006 Boehringer Ingelheim Investigational Site | Isesaki, Gunma | Japan |
| 1218.64.81001 Boehringer Ingelheim Investigational Site | Meguro-ku, Tokyo | Japan |
| 1218.64.81008 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1218.64.81007 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1218.64.81002 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1218.64.81004 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
| 1218.64.81003 Boehringer Ingelheim Investigational Site | Suwa, Nagano | Japan |
| 1218.64.64001 Boehringer Ingelheim Investigational Site | Otahuhu Auckland | New Zealand |
| 1218.64.42102 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.64.42107 Boehringer Ingelheim Investigational Site | Košice | Slovakia |
| 1218.64.42109 Boehringer Ingelheim Investigational Site | Nitra | Slovakia |
| 1218.64.42108 Boehringer Ingelheim Investigational Site | Trenčín | Slovakia |
| 1218.64.46002 Boehringer Ingelheim Investigational Site | Härnösand | Sweden |
| 1218.64.46003 Boehringer Ingelheim Investigational Site | Helsingborg | Sweden |
Patients randomized to receive treatment with Linagliptin 5mg
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Up to Final Analysis (Week 52) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Glimepiride | Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks. |
| BG001 | Linagliptin 5 mg | 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 | Age Continuous for patient set up to 52 weeks | Mean | Standard Deviation | Years |
| ||||||||||||||
| Age, Continuous | Age Continuous for patient set up to 12 weeks (N=123, 118, 241) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Gender for patient set up to 52 weeks. | Count of Participants | Participants |
| |||||||||||||||
| Gender | Gender for patient set up to 12 weeks (N=123, 118, 241) | Number | participants |
| |||||||||||||||
| Body mass index (BMI) continuous | BMI for patient set up to 52 weeks. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Body mass index (BMI) continuous | BMI for patient set up to 12 weeks (N=123, 118, 241) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Glycosylated Hemoglobin A1 (HbA1c) | HbA1c based on Full analysis set (FAS) up to 52 weeks (N=120, 113, 233) | Mean | Standard Deviation | Percent |
| ||||||||||||||
| Glycosylated Hemoglobin A1 (HbA1c) | HbA1c based on Full analysis set (FAS) up to 12 weeks (N=121, 117, 238) | Mean | Standard Deviation | Percent |
| ||||||||||||||
| Fasting Plasma Glucose (FPG) | FPG based on Full analysis set (FAS) up to 52 weeks (N=120, 113, 233) | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Fasting Plasma Glucose (FPG) | FPG based on FAS up to 12 weeks (N=121, 117, 238) | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| eGFR based on Modification of Diet in Renal Disease (MDRD) formula | eGFR based on FAS up to 52 weeks (N=122, 113, 235). eGFR means Estimated glomerular filtration rate. | Number | Participants |
| |||||||||||||||
| eGFR based on Modification of Diet in Renal Disease (MDRD) formula | eGFR based on FAS up to 12 weeks (N=123, 118, 241). eGFR means Estimated glomerular filtration rate. | Number | participants |
|
| 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 to 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, renal function impairment and prior use of antidiabetic agents. | FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule. Results for primary endpoint below are the ones reproduced without patients from the excluded study site. | Posted | Mean | Standard Error | Percent | Baseline and week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Change From Baseline Over Time | HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling. | FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site. | Posted | Mean | Standard Deviation | Percent | Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline to 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 prior use of insulin, week repeated within patient and week by treatment interaction. | One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site. | Posted | Mean | Standard Error | mg/dL | Baseline and week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline Over Time | This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling. | FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site. | Posted | Mean | Standard Deviation | mg/dL | Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <7.0% | The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%. | FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site. | Posted | Number | percentage of patients | Baseline, week 12 and week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With HbA1c <6.5% | The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%. | FAS with baseline HbA1c >=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site. | Posted | Number | percentage of patients | Baseline, week 12 and week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% | The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%. | FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site. | Posted | Number | percentage of patients | Baseline, week 12 and week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Linagliptin at Trough | Trough levels of concentration of Linagliptin in plasma. | FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nmol/L | Week 12, 24 and 52 |
|
|
52 weeks
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/Glimepiride | Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks. | 36 | 122 | 110 | 122 | ||
| EG001 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5mg | 28 | 113 | 95 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 15.0 |
| ||
| Cellulitis | Infections and infestations | MedDRA 15.0 |
| ||
| Gastroenteritis | Infections and infestations | MedDRA 15.0 |
| ||
| Sepsis | Infections and infestations | MedDRA 15.0 |
| ||
| Acarodermatitis | Infections and infestations | MedDRA 15.0 |
| ||
| Gas gangrene | Infections and infestations | MedDRA 15.0 |
| ||
| Labyrinthitis | Infections and infestations | MedDRA 15.0 |
| ||
| Localised infection | Infections and infestations | MedDRA 15.0 |
| ||
| Osteomyelitis | Infections and infestations | MedDRA 15.0 |
| ||
| Device related infection | Infections and infestations | MedDRA 15.0 |
| ||
| Endocarditis enterococcal | Infections and infestations | MedDRA 15.0 |
| ||
| Lymphangitis | Infections and infestations | MedDRA 15.0 |
| ||
| Otitis externa | Infections and infestations | MedDRA 15.0 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 15.0 |
| ||
| Viral infection | Infections and infestations | MedDRA 15.0 |
| ||
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Fluid overload | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Panic attack | Psychiatric disorders | MedDRA 15.0 |
| ||
| Cerebral infarction | Nervous system disorders | MedDRA 15.0 |
| ||
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA 15.0 |
| ||
| Paraesthesia | Nervous system disorders | MedDRA 15.0 |
| ||
| Syncope | Nervous system disorders | MedDRA 15.0 |
| ||
| Brachial plexopathy | Nervous system disorders | MedDRA 15.0 |
| ||
| Retinal haemorrhage | Eye disorders | MedDRA 15.0 |
| ||
| Amaurosis fugax | Eye disorders | MedDRA 15.0 |
| ||
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 |
| ||
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 |
| ||
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 |
| ||
| Angina pectoris | Cardiac disorders | MedDRA 15.0 |
| ||
| Angina unstable | Cardiac disorders | MedDRA 15.0 |
| ||
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 |
| ||
| Bradycardia | Cardiac disorders | MedDRA 15.0 |
| ||
| Diastolic dysfunction | Cardiac disorders | MedDRA 15.0 |
| ||
| Palpitations | Cardiac disorders | MedDRA 15.0 |
| ||
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 |
| ||
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 15.0 |
| ||
| Orthostatic hypotension | Vascular disorders | MedDRA 15.0 |
| ||
| Peripheral ischaemia | Vascular disorders | MedDRA 15.0 |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 15.0 |
| ||
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 |
| ||
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 15.0 |
| ||
| Renal failure chronic | Renal and urinary disorders | MedDRA 15.0 |
| ||
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 |
| ||
| Nephropathy toxic | Renal and urinary disorders | MedDRA 15.0 |
| ||
| Chest pain | General disorders | MedDRA 15.0 |
| ||
| Oedema peripheral | General disorders | MedDRA 15.0 |
| ||
| Fatigue | General disorders | MedDRA 15.0 |
| ||
| Liver function test abnormal | Investigations | MedDRA 15.0 |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 15.0 |
| ||
| Bronchitis | Infections and infestations | MedDRA 15.0 |
| ||
| Influenza | Infections and infestations | MedDRA 15.0 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 |
| ||
| Headache | Nervous system disorders | MedDRA 15.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA 15.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 15.0 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
| ||
| Oedema peripheral | General disorders | MedDRA 15.0 |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
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 |
|---|---|
| C057619 | glimepiride |
| 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
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Study site excluded from analysis |
|
| Other reason not described above |
|
| Male |
|
| Male |
|
| 60 to <90 (mild renal impairment) |
|
| 30 to <60 (moderate renal impairment) |
|
| <30 (severe or endstage renal impairment) |
|
| 60 to <90 (mild renal impairment) |
|
| 30 to <60 (moderate renal impairment) |
|
| <30 (severe or endstage renal impairment) |
|
|
|
|
|
|
|
|
|