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This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events and Serious Adverse Events | Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 of HbA1c | Change from baseline to week 24 of glycosylated hemoglobin (HbA1c) | Baseline and 24 weeks |
| Change From Baseline to Week 24 of Fasting Blood Sugar | Change from baseline to week 24 of fasting blood sugar |
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Inclusion criteria:
Exclusion criteria:
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Filipino type 2 DM patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 43 | Agoo, La Union | Philippines | ||||
| Boehringer Ingelheim Investigational Site 40 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Linagliptin | Linagliptin 5 mg was administered orally once a day for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and 24 weeks |
| Angeles City, Pampanga |
| Philippines |
| Boehringer Ingelheim Investigational Site 31 | Angono, Rizal | Philippines |
| Boehringer Ingelheim Investigational Site 32 | Antipolo, Rizal | Philippines |
| Boehringer Ingelheim Investigational Site 27 | Aparri, Cagayan | Philippines |
| Boehringer Ingelheim Investigational Site 4 | Batangas | Philippines |
| Boehringer Ingelheim Investigational Site 48 | Butuan City, Agusan Del Norte | Philippines |
| Boehringer Ingelheim Investigational Site 12 | Cabanatuan, Nueva Ecija | Philippines |
| Boehringer Ingelheim Investigational Site 23 | Cagayan de Oro | Philippines |
| Boehringer Ingelheim Investigational Site 3 | Caloocan | Philippines |
| Boehringer Ingelheim Investigational Site 42 | Cardona, Rizal | Philippines |
| Boehringer Ingelheim Investigational Site 25 | Cebu | Philippines |
| Boehringer Ingelheim Investigational Site 44 | Dagupan, Pangasinan | Philippines |
| Boehringer Ingelheim Investigational Site 49 | Iligan City, Lanao Del Norte | Philippines |
| Boehringer Ingelheim Investigational Site 2 | Iloilo City | Philippines |
| Boehringer Ingelheim Investigational Site 45 | Iriga City, Camarines Sur | Philippines |
| Boehringer Ingelheim Investigational Site 20 | Laoag, Ilocos Norte | Philippines |
| Boehringer Ingelheim Investigational Site 24 | Las Piñas | Philippines |
| Boehringer Ingelheim Investigational Site 7 | Legazpi, Albay | Philippines |
| Boehringer Ingelheim Investigational Site 35 | Lucena, Quezon | Philippines |
| Boehringer Ingelheim Investigational Site 1 | Makati | Philippines |
| Boehringer Ingelheim Investigational Site 39 | Malolos, Bulacan | Philippines |
| Boehringer Ingelheim Investigational Site 37 | Mandaluyong | Philippines |
| Boehringer Ingelheim Investigational Site 28 | Manila | Philippines |
| Boehringer Ingelheim Investigational Site 5 | Marikina City | Philippines |
| Boehringer Ingelheim Investigational Site 16 | Meycauyan, Bulacan | Philippines |
| Boehringer Ingelheim Investigational Site 47 | Naga City, Camarines Sur | Philippines |
| Boehringer Ingelheim Investigational Site 15 | Olongapo City | Philippines |
| Boehringer Ingelheim Investigational Site 10 | Pampanga | Philippines |
| Boehringer Ingelheim Investigational Site 19 | Paranaque City | Philippines |
| Boehringer Ingelheim Investigational Site 51 | Pasay | Philippines |
| Boehringer Ingelheim Investigational Site 30 | Pasig | Philippines |
| Boehringer Ingelheim Investigational Site 34 | Puerto Princesa, Palawan | Philippines |
| Boehringer Ingelheim Investigational Site 26 | Quezon City | Philippines |
| Boehringer Ingelheim Investigational Site 11 | Rosales, Pangasinan | Philippines |
| Boehringer Ingelheim Investigational Site 21 | San Fernando, La Union | Philippines |
| Boehringer Ingelheim Investigational Site 9 | San Fernando, Pampanga | Philippines |
| Boehringer Ingelheim Investigational Site 13 | San Jose, Nueva Ecija | Philippines |
| Boehringer Ingelheim Investigational Site 29 | San Juan City | Philippines |
| Boehringer Ingelheim Investigational Site 8 | San Pablo, Laguna | Philippines |
| Boehringer Ingelheim Investigational Site 50 | San Pedro, Laguna | Philippines |
| Boehringer Ingelheim Investigational Site 41 | Santiago City, Isabela | Philippines |
| Boehringer Ingelheim Investigational Site 36 | Sogod, Southern Leyte | Philippines |
| Boehringer Ingelheim Investigational Site 38 | Sta.Maria, Bulacan | Philippines |
| Boehringer Ingelheim Investigational Site 6 | Tacloban City | Philippines |
| Boehringer Ingelheim Investigational Site 33 | Tagbilaran, Bohol | Philippines |
| Boehringer Ingelheim Investigational Site 14 | Tuguegarao, Cagayan | Philippines |
| Boehringer Ingelheim Investigational Site 18 | Urdaneta, Pangasinan | Philippines |
| Boehringer Ingelheim Investigational Site 46 | Valencia City Bukidnon | Philippines |
| Boehringer Ingelheim Investigational Site 17 | Valenzuela, Bulacan | Philippines |
| Boehringer Ingelheim Investigational Site 22 | Zamboanga City | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Linagliptin | Linagliptin 5 mg was administered orally once a day for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age information is missing for 5 patients | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Gender | Gender information is missing for 4 patients | 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 | Frequency of Adverse Events and Serious Adverse Events | Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events. | Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation. | Posted | Number | percentage of participants | Week 24 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 of HbA1c | Change from baseline to week 24 of glycosylated hemoglobin (HbA1c) | Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline and 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 of Fasting Blood Sugar | Change from baseline to week 24 of fasting blood sugar | Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar. | Posted | Mean | Standard Deviation | mg/dl | Baseline and 24 weeks |
|
|
24 weeks
Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.
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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 | Linagliptin | Linagliptin 5 mg was administered orally once a day for 24 weeks | 0 | 660 | 0 | 660 |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| 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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