Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004597-24 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin low dose | Experimental | Patients receive Linagliptin low dose tablets once daily |
|
| Linagliptin medium dose | Experimental | Patients receive Linagliptin medium dose tablets once daily |
|
| Linagliptin high dose | Experimental | Patients receive Linagliptin high dose tablets once daily |
|
| Placebo | Placebo Comparator | Patients receive tablets identical to those containing Linagliptin low, medium and high dose |
|
| Glimepiride | Active Comparator | Patients receive Glimepiride tablets once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | Linagliptin medium dose tablet once 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 HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With HbA1c<=7.0% at Week 12 | Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12. | week 12 |
| Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12 |
Not provided
Inclusion criteria:
Inclusion_Criteria:
Exclusion 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 |
|---|---|---|---|---|---|---|
| 1218.6.3302A Boehringer Ingelheim Investigational Site | Joué Les Tours | France | ||||
| 1218.6.3303A Boehringer Ingelheim Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| FG001 | Linagliptin 1 mg | Patients randomized to receive treatment with Linagliptin 1 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Linagliptin |
| Drug |
Linagliptin high dose tablet once daily |
|
| Linagliptin | Drug | Linagliptin low dose tablet once daily |
|
| Placebo | Drug | Placebo tablets once daily |
|
| Glimepiride | Drug | Glimepiride tablets once daily |
|
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 |
| Joué Les Tours |
| France |
| 1218.6.3304A Boehringer Ingelheim Investigational Site | Joué-lès-Tours | France |
| 1218.6.3305A Euraxi Pharma | Joué-lès-Tours | France |
| 1218.6.3301A Boehringer Ingelheim Investigational Site | Paris | France |
| 1218.6.49007 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany |
| 1218.6.49013 Boehringer Ingelheim Investigational Site | Bosenheim | Germany |
| 1218.6.49008 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1218.6.49009 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1218.6.49014 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1218.6.49012 Boehringer Ingelheim Investigational Site | Immenstadt im Allgäu | Germany |
| 1218.6.49001 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1218.6.49005 Boehringer Ingelheim Investigational Site | Neuwied | Germany |
| 1218.6.49017 Boehringer Ingelheim Investigational Site | Offenbach A. M. | Germany |
| 1218.6.49002 Boehringer Ingelheim Investigational Site | Saarbrücken | Germany |
| 1218.6.49010 Boehringer Ingelheim Investigational Site | Saint Ingbert/Oberwürzbach | Germany |
| 1218.6.49011 Boehringer Ingelheim Investigational Site | Sinsheim | Germany |
| 1218.6.49015 Boehringer Ingelheim Investigational Site | Sulzbach-Rosenberg | Germany |
| 1218.6.49016 Boehringer Ingelheim Investigational Site | Wangen | Germany |
| 1218.6.49003 Boehringer Ingelheim Investigational Site | Würzburg | Germany |
| 1218.6.42103 Boehringer Ingelheim Investigational Site | Banská Bystrica | Slovakia |
| 1218.6.42104 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.6.42105 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.6.42101 Boehringer Ingelheim Investigational Site | Nové Mesto nad Váhom | Slovakia |
| 1218.6.46003 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1218.6.46001 Boehringer Ingelheim Investigational Site | Malmö | Sweden |
| 1218.6.46002 Boehringer Ingelheim Investigational Site | Uddevalla | Sweden |
| 1218.6.46004 Boehringer Ingelheim Investigational Site | Uppsala | Sweden |
| 1218.6.38002 Boehringer Ingelheim Investigational Site | Dnyepropetrovsk | Ukraine |
| 1218.6.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.6.38003 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.6.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.6.44012 Boehringer Ingelheim Investigational Site | Ashford | United Kingdom |
| 1218.6.44004 Boehringer Ingelheim Investigational Site | Baillieston, Glasgow | United Kingdom |
| 1218.6.44002 Boehringer Ingelheim Investigational Site | Bath | United Kingdom |
| 1218.6.44003 Boehringer Ingelheim Investigational Site | Birmingham | United Kingdom |
| 1218.6.44013 Boehringer Ingelheim Investigational Site | Camberley | United Kingdom |
| 1218.6.44016 Boehringer Ingelheim Investigational Site | Chorley | United Kingdom |
| 1218.6.44007 Boehringer Ingelheim Investigational Site | Dundee | United Kingdom |
| 1218.6.44006 Boehringer Ingelheim Investigational Site | Exeter | United Kingdom |
| 1218.6.44005 Boehringer Ingelheim Investigational Site | Gillingham | United Kingdom |
| 1218.6.44015 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom |
| 1218.6.44008 Boehringer Ingelheim Investigational Site | Guildford | United Kingdom |
| 1218.6.44017 Boehringer Ingelheim Investigational Site | Liverpool | United Kingdom |
| 1218.6.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1218.6.44018 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
| 1218.6.44009 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | United Kingdom |
| 1218.6.44019 Boehringer Ingelheim Investigational Site | Reading | United Kingdom |
| FG002 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5 mg |
| FG003 | Linagliptin 10 mg | Patients randomized to receive treatment with Linagliptin 10 mg |
| FG004 | Glimepiride | Patients randomized to receive treatment with Glimepiride |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients randomized to receive treatment with matching placebo |
| BG001 | Linagliptin 1 mg | Patients randomized to receive treatment with Linagliptin 1 mg |
| BG002 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5 mg |
| BG003 | Linagliptin 10 mg | Patients randomized to receive treatment with Linagliptin 10 mg |
| BG004 | Glimepiride | Patients randomized to receive treatment with Glimepiride |
| BG005 | 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) continuous | Mean | Standard Deviation | Percent |
| |||||||||||||||
| Fasting plasma glucose (FPG) continuous | 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 HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c. | 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 | Percentage of Patients With HbA1c<=7.0% at Week 12 | Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12. | This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Number | Percentage of Patients | week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Blood Plasma Glucose Level (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 |
|
12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
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 | 1 | 71 | 10 | 71 | ||
| EG001 | Linagliptin 1 mg | Patients randomized to receive treatment with Linagliptin 1 mg | 3 | 65 | 4 | 65 | ||
| EG002 | Linagliptin 5 mg | Patients randomized to receive treatment with Linagliptin 5 mg | 1 | 66 | 8 | 66 | ||
| EG003 | Linagliptin 10 mg | Patients randomized to receive treatment with Linagliptin 10 mg | 4 | 66 | 8 | 66 | ||
| EG004 | Glimepiride | Patients randomized to receive treatment with Glimepiride | 1 | 65 | 4 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders |
| |||
| Coronary artery disease | Cardiac disorders |
| |||
| Myocardial infarction | Cardiac disorders |
| |||
| Goitre | Endocrine disorders |
| |||
| Chest pain | General disorders |
| |||
| Flank pain | Musculoskeletal and connective tissue disorders |
| |||
| Hemiparesis | Nervous system disorders |
| |||
| Confusional state | Psychiatric disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Renal mass | Renal and urinary disorders |
| |||
| Urinary tract obstruction | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | 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 |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Male |
|
| Linagliptin 5 mg vs. Placebo missing endpoints after 12 weeks of treatment were replaced using "Last Observation Carried Forward" (LOCF) | Pairwise comparison based on ANCOVA | <0.0001 | There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg. | Mean Difference (Final Values) | -0.73 | Standard Error of the Mean | 0.14 | 95 | -1.01 | -0.44 | No | Superiority or Other |
| Linagliptin 1 mg vs. Placebo Missing endpoints after 12 weeks of treatment were replaced using "Last Observation Carried Forward" (LOCF) | Pairwise comparison based on ANCOVA | 0.0055 | There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg. | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 0.14 | 95 | -0.68 | -0.12 | No | Superiority or Other |
| Placebo vs. Linagliptin 10 mg Analysis additionally adjusted for previous anti-diabetic medication. Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF). | Pairwise comparison based on ANCOVA | <0.0001 | Mean Difference (Final Values) | -0.73 | Standard Error of the Mean | 0.14 | 95 | -0.99 | -0.46 | No | Superiority or Other |
| Linagliptin 5 mg vs. Placebo Analysis additionally adjusted for previous anti-diabetic medication. Missing endpoints after 12 weeks of treatment were replaced using "last observation carried forward" (LOCF). | Pairwise comparison based on ANCOVA | <0.0001 | Mean Difference (Final Values) | -0.75 | Standard Error of the Mean | 0.14 | 95 | -1.02 | -0.48 | No | Superiority or Other |
| Linagliptin 1 mg vs. Placebo Analysis additionally adjusted for previous anti-diabetic medication. Missing endpoints after 12 weeks of treatment were replaced using "last observation carried forward" (LOCF). | Pairwise comparison based on ANCOVA | 0.0049 | Mean Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.14 | 95 | -0.66 | -0.12 | No | Superiority or Other |
Patients randomized to receive treatment with Glimepiride
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|