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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003118-86 | EudraCT Number | EudraCT |
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Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1356 | Active Comparator | 5 mg orally (po) once daily |
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| Placebo | Placebo Comparator | one tablet once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1356 | Drug | 5mg orally (po) tablet qd |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 18 | Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 18 |
| Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 |
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Inclusion criteria:
Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug
Exclusion criteria:
Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.35.10002 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |||
| 1218.35.10001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24169807 | Derived | McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29. | |
| 22939034 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo tablet taken orally once daily |
| FG001 | Linagliptin (BI 1356) 5.0 mg | Linagliptin 5.0 mg tablet taken orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Placebo matching BI 1356 5mg one tablet daily |
|
An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks. |
| week 18 |
| Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 | An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks. | week 18 |
| Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 | An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks. | Baseline, week 18 |
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 | HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 6 |
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 12 |
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 18 |
| Change From Baseline in Fasting Plasma Glucose at Week 6 | Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 6 |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 12 |
| Los Angeles |
| California |
| United States |
| 1218.35.10016 Boehringer Ingelheim Investigational Site | National City | California | United States |
| 1218.35.10017 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States |
| 1218.35.10021 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States |
| 1218.35.10013 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1218.35.10015 Boehringer Ingelheim Investigational Site | Flint | Michigan | United States |
| 1218.35.10018 Boehringer Ingelheim Investigational Site | Asheville | North Carolina | United States |
| 1218.35.10004 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 1218.35.10005 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States |
| 1218.35.10020 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1218.35.10009 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.35.10019 Boehringer Ingelheim Investigational Site | Sugar Land | Texas | United States |
| 1218.35.54003 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1218.35.54005 Boehringer Ingelheim Investigational Site | Corrientes | Argentina |
| 1218.35.54001 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina |
| 1218.35.54006 Boehringer Ingelheim Investigational Site | Parque Velez Sarfield | Argentina |
| 1218.35.36001 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.35.36002 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.35.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.35.36005 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.35.36003 Boehringer Ingelheim Investigational Site | Debrecen | Hungary |
| 1218.35.91003 Boehringer Ingelheim Investigational Site | Aligarh, Uttar Pradesh | India |
| 1218.35.91007 Boehringer Ingelheim Investigational Site | Aminjikarai, Tamilnadu | India |
| 1218.35.91001 Boehringer Ingelheim Investigational Site | Bangalore, Karnataka | India |
| 1218.35.91004 Boehringer Ingelheim Investigational Site | Bangalore, Karnataka | India |
| 1218.35.91002 Boehringer Ingelheim Investigational Site | Indore | India |
| 1218.35.91008 Boehringer Ingelheim Investigational Site | Mumbai, Maharastra | India |
| 1218.35.91005 Boehringer Ingelheim Investigational Site | Nagpur, Maharashtra | India |
| 1218.35.91006 Boehringer Ingelheim Investigational Site | Pune, Maharastra | India |
| 1218.35.81003 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1218.35.81001 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1218.35.81002 Boehringer Ingelheim Investigational Site | Suita, Osaka, | Japan |
| 1218.35.48002 Boehringer Ingelheim Investigational Site | Bialystok | Poland |
| 1218.35.48004 Boehringer Ingelheim Investigational Site | Lublin | Poland |
| 1218.35.48003 Boehringer Ingelheim Investigational Site | Poznan | Poland |
| 1218.35.48001 Boehringer Ingelheim Investigational Site | Rzeszów | Poland |
| 1218.35.48005 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| 1218.35.70008 Boehringer Ingelheim Investigational Site | Arkhangelsk | Russia |
| 1218.35.70001 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.35.70002 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.35.70003 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.35.70006 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.35.70009 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.35.70007 Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| Lewin AJ, Arvay L, Liu D, Patel S, von Eynatten M, Woerle HJ. Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Sep;34(9):1909-19.e15. doi: 10.1016/j.clinthera.2012.07.008. Epub 2012 Aug 29. |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo tablet taken orally once daily |
| BG001 | Linagliptin 5.0 mg | Linagliptin 5.0 mg tablet taken orally once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/square meter |
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| Baseline glycosylated hemoglobin (HbA1c) | Mean | Standard Deviation | percentage |
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| Fasting blood plasma glucose (FPG) | Mean | Standard Deviation | milligram/deciliter (mg/dL) |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | percent | Baseline, week 18 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 18 | Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, week 18 |
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| Secondary | Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 | An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks. | FAS patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF). | Posted | Number | Percentage of Patients | week 18 |
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| Secondary | Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 | An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks. | FAS patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of participants | week 18 |
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| Secondary | Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 | An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks. | FAS patients. Non-completers were considered as failure imputation (NCF). | Posted | Number | percentage of participants | Baseline, week 18 |
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| Secondary | Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 | HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC). | Posted | Least Squares Mean | Standard Error | percent | Baseline, week 6 |
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| Secondary | Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC). | Posted | Least Squares Mean | Standard Error | percent | Baseline, week 12 |
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| Secondary | Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC). | Posted | Least Squares Mean | Standard Error | percent | Baseline, week 18 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 6 | Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, week 6 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, week 12 |
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From day of first dose until 7 days after last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo tablet taken orally once daily | 1 | 84 | 14 | 84 | ||
| EG001 | Linagliptin 5.0 mg | Linagliptin 5.0 mg tablet taken orally once daily | 5 | 161 | 14 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 12.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 12.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA version 12.1 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA version 12.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA version 12.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 12.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA version 12.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA version 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 12.1 | Systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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