Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013549-27 | EudraCT Number | EudraCT |
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The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin low dose | Experimental | linagliptin low dose twice daily |
|
| placebo | Placebo Comparator | placebo matching linagliptin |
|
| linagliptin medium dose | Experimental | linagliptin medium dose once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptin low dose | Drug | patient to receive tablets containing low dose linagliptin twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | Baseline and week 6 |
| HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.62.32003 Boehringer Ingelheim Investigational Site | De Pinte | Belgium | ||||
| 1218.62.32008 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22816729 | Derived | Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. doi: 10.1185/03007995.2012.714360. Epub 2012 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients treated with matching placebo |
| FG001 | Lina 2.5 Twice Daily (Bid) | Patients treated with Linagliptin 2.5mg bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| placebo | Drug | patient to receive placebo tablet(s) matching linagliptin |
|
| linagliptin medium dose | Drug | patient to receive a tablet containing medium dose linagliptin once daily |
|
Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. |
| Baseline and week 12 |
| FPG Change From Baseline at Week 12 | Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin. | Baseline and week 12 |
| FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | Baseline and week 6 |
| FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | Baseline and week 12 |
| Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12 | Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF. | Week 12 |
| Percentage of Patients With Rescue Therapy | Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC. | 12 weeks |
| The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment | Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF. | 12 weeks |
| The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment | Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF. | 12 weeks |
| Kortenaken |
| Belgium |
| 1218.62.32009 Boehringer Ingelheim Investigational Site | Kumtich | Belgium |
| 1218.62.32005 Boehringer Ingelheim Investigational Site | Massemen-Wetteren | Belgium |
| 1218.62.32004 Boehringer Ingelheim Investigational Site | Natoye | Belgium |
| 1218.62.32007 Boehringer Ingelheim Investigational Site | Sint-Job-in't-Goor | Belgium |
| 1218.62.32002 Boehringer Ingelheim Investigational Site | Tessenderlo | Belgium |
| 1218.62.32006 Boehringer Ingelheim Investigational Site | Wilsele | Belgium |
| 1218.62.11012 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1218.62.11007 Boehringer Ingelheim Investigational Site | Burnaby | British Columbia | Canada |
| 1218.62.11011 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador | Canada |
| 1218.62.11006 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| 1218.62.11001 Boehringer Ingelheim Investigational Site | Barrie | Ontario | Canada |
| 1218.62.11003 Boehringer Ingelheim Investigational Site | Brampton | Ontario | Canada |
| 1218.62.11004 Boehringer Ingelheim Investigational Site | Markham | Ontario | Canada |
| 1218.62.11005 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.62.11008 Boehringer Ingelheim Investigational Site | Smiths Falls | Ontario | Canada |
| 1218.62.11013 Boehringer Ingelheim Investigational Site | Strathroy | Ontario | Canada |
| 1218.62.11014 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.62.11010 Boehringer Ingelheim Investigational Site | Charlottetown | Prince Edward Island | Canada |
| 1218.62.11002 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1218.62.11009 Boehringer Ingelheim Investigational Site | Point Claire | Quebec | Canada |
| 1218.62.3303C Boehringer Ingelheim Investigational Site | Bort-les-Orgues | France |
| 1218.62.3306A Boehringer Ingelheim Investigational Site | Bourg Des Cptes | France |
| 1218.62.3303D Boehringer Ingelheim Investigational Site | Bugeat | France |
| 1218.62.3302H Boehringer Ingelheim Investigational Site | Corsept | France |
| 1218.62.3308A Boehringer Ingelheim Investigational Site | Derval | France |
| 1218.62.3302B Boehringer Ingelheim Investigational Site | La Chapelle-sur-Erdre | France |
| 1218.62.3304A Boehringer Ingelheim Investigational Site | Levallois-Perret | France |
| 1218.62.3305A Boehringer Ingelheim Investigational Site | Marseille | France |
| 1218.62.3305B Boehringer Ingelheim Investigational Site | Marseille | France |
| 1218.62.3305G Boehringer Ingelheim Investigational Site | Marseille | France |
| 1218.62.3305H Boehringer Ingelheim Investigational Site | Marseille | France |
| 1218.62.3301A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1218.62.3302A Boehringer Ingelheim Investigational Site | Nantes | France |
| 1218.62.3304B Boehringer Ingelheim Investigational Site | Paris | France |
| 1218.62.3304D Boehringer Ingelheim Investigational Site | Paris | France |
| 1218.62.3305F Boehringer Ingelheim Investigational Site | Roquevaire | France |
| 1218.62.3305I Boehringer Ingelheim Investigational Site | Roquevaire | France |
| 1218.62.3303A Boehringer Ingelheim Investigational Site | Rosiers-d'Égletons | France |
| 1218.62.3303H Boehringer Ingelheim Investigational Site | Sainte-Fortunade | France |
| 1218.62.3302I Boehringer Ingelheim Investigational Site | Sautron | France |
| 1218.62.3302G Boehringer Ingelheim Investigational Site | Vue | France |
| 1218.62.91001 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.62.91004 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.62.91003 Boehringer Ingelheim Investigational Site | Hyderabad, Andra Pradesh | India |
| 1218.62.91005 Boehringer Ingelheim Investigational Site | Nagpru | India |
| 1218.62.91002 Boehringer Ingelheim Investigational Site | Trivandrum | India |
| 1218.62.39010 Boehringer Ingelheim Investigational Site | Ancona | Italy |
| 1218.62.39006 Boehringer Ingelheim Investigational Site | Catania | Italy |
| 1218.62.39004 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1218.62.39009 Boehringer Ingelheim Investigational Site | Gissi (CH) | Italy |
| 1218.62.39003 Boehringer Ingelheim Investigational Site | Palermo | Italy |
| 1218.62.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1218.62.39002 Boehringer Ingelheim Investigational Site | Pordenone | Italy |
| 1218.62.39012 Boehringer Ingelheim Investigational Site | Ravenna | Italy |
| 1218.62.39007 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1218.62.39011 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1218.62.60002 Boehringer Ingelheim Investigational Site | George Town | Malaysia |
| 1218.62.60001 Boehringer Ingelheim Investigational Site | Kelantan Kota Bahru | Malaysia |
| 1218.62.60005 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1218.62.60003 Boehringer Ingelheim Investigational Site | Putrajaya | Malaysia |
| 1218.62.60004 Boehringer Ingelheim Investigational Site | Seremban | Malaysia |
| 1218.62.31007 Boehringer Ingelheim Investigational Site | Almere Stad | Netherlands |
| 1218.62.31004 Boehringer Ingelheim Investigational Site | Breezerveld | Netherlands |
| 1218.62.31005 Boehringer Ingelheim Investigational Site | Etten-Leur | Netherlands |
| 1218.62.31002 Boehringer Ingelheim Investigational Site | Lieshout | Netherlands |
| 1218.62.31001 Boehringer Ingelheim Investigational Site | Oude Pekela | Netherlands |
| 1218.62.31008 Boehringer Ingelheim Investigational Site | Voerendaal | Netherlands |
| 1218.62.31009 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands |
| 1218.62.31003 Boehringer Ingelheim Investigational Site | Woerden | Netherlands |
| 1218.62.82005 Boehringer Ingelheim Investigational Site | Goyang | South Korea |
| 1218.62.82006 Boehringer Ingelheim Investigational Site | Goyang | South Korea |
| 1218.62.82003 Boehringer Ingelheim Investigational Site | Incheon | South Korea |
| 1218.62.82004 Boehringer Ingelheim Investigational Site | Pucheon | South Korea |
| 1218.62.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.62.82001 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1218.62.34003 Boehringer Ingelheim Investigational Site | Badia Del Vallés (Barcelona) | Spain |
| 1218.62.34002 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1218.62.34005 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.62.34006 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.62.34007 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.62.34001 Boehringer Ingelheim Investigational Site | Palma (Mallorca) | Spain |
| 1218.62.34008 Boehringer Ingelheim Investigational Site | Palma de Mallorca | Spain |
| FG002 | Lina 5 Once Daily (qd) | Patients treated with Linagliptin 5mg qd |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients treated with matching placebo |
| BG001 | Lina 2.5 Twice Daily (Bid) | Patients treated with Linagliptin 2.5mg bid |
| BG002 | Lina 5 Once Daily (qd) | Patients treated with Linagliptin 5mg qd |
| BG003 | 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 (HbA1c) | Baseline HbA1c was determined for the Full Analysis Set with 43 patients treated with Placebo, 214 patients treated with Linagliptin 2.5 bid and 221 patients treated with Linagliptin 5mg qd (478 in total). | Mean | Standard Deviation | percent |
| ||||||||||||||
| Fasting blood plasma glucose (FPG) | Baseline FPG was determined for the Full Analysis Set (where FPG values were also available) with 41 patients treated with Placebo, 209 patients treated with Linagliptin 2.5 bid and 216 patients treated with Linagliptin 5mg qd (466 in total). | 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 12 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin. | The Full Analysis Set (FAS) included all treated 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 |
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| Secondary | HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model. | Posted | Mean | Standard Error | percent | Baseline and week 6 |
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| Secondary | HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model. | Posted | Mean | Standard Error | percent | Baseline and week 12 |
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| Secondary | FPG Change From Baseline at Week 12 | Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin. | Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Mean | Standard Error | mg/dL | Baseline and week 12 |
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| Secondary | FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model. | Posted | Mean | Standard Error | percent | Baseline and week 6 |
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| Secondary | FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis | Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction. | Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model. | Posted | Mean | Standard Error | percent | Baseline and week 12 |
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| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12 | Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF. | The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders | Posted | Number | percent | Week 12 |
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| Secondary | Percentage of Patients With Rescue Therapy | Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC. | Posted | Number | percent | 12 weeks |
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| Secondary | The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment | Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF. | FAS (NCF) with baseline HbA1c >= 7.0% | Posted | Number | percentage of participants | 12 weeks |
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| Secondary | The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment | Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF. | FAS (NCF) with baseline HbA1c >= 6.5% | Posted | Number | percentage of participants | 12 weeks |
|
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up to 12 weeks (drug stop) + 7 days (follow-up)
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 treated with matching placebo | 0 | 44 | 0 | 44 | ||
| EG001 | Lina 2.5 Twice Daily (Bid) | Patients treated with Linagliptin 2.5mg bid | 9 | 223 | 0 | 223 | ||
| EG002 | Lina 5 Once Daily (qd) | Patients treated with Linagliptin 5mg qd | 5 | 224 | 0 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Open fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Preoperative care | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
|
Not provided
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 |
|
| ANCOVA |
| <0.0001 |
| Mean Difference (Final Values) |
| -0.80 |
| Standard Error of the Mean |
| 0.11 |
| 95 |
| -1.02 |
| -0.58 |
| No |
| Superiority or Other |
| Linagliptin 2.5mg bid versus Linagliptin 5mg qd | ANCOVA | Mean Difference (Final Values) | 0.06 | Standard Error of the Mean | 0.07 | 95 | -0.07 | 0.19 | Yes | Non-Inferiority or Equivalence | The pre-defined non-inferiority margin was +0.35 |
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