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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000750-13 | EudraCT Number | EudraCT |
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The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin 5 mg | Experimental | open label |
|
| linagliptin 5 mg and pioglitazone 30 mg | Experimental | open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linagliptine 5 mg | Drug | safety and efficacy of linagliptine 5 mg open label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Patients With Adverse Events (AEs) | This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures. | 78 weeks |
| Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events | 78 weeks | |
| Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ) | As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis''). | 78 weeks |
| Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events | Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC) | 78 weeks |
| Number of Patients With Abnormalities in Vital Signs | Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events) | 78 weeks |
| Number of Patients With Abnormalities in Haematology: Eosinophils | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%. | 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 6 | Baseline and week 6 | |
| Change in HbA1c From Baseline to Week 18 | Baseline and week 18 | |
| Change in HbA1c From Baseline to Week 30 |
Not provided
Inclusion criteria:
Exclusion criteria:
Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent) who:
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.40.10003 Boehringer Ingelheim Investigational Site | Chula Vista | California | United States | |||
| 1218.40.10014 Boehringer Ingelheim Investigational Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Old Lina | Patients pre-treated with linagliptin (BI 1356) |
| FG001 | New Lina | Patients pre-treated with placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| linagliptine 5 mg and pioglitazone 30 mg |
| Drug |
efficacy and safety of the combination linagliptine and pioglitazone |
|
| Number of Patients With Abnormalities in Haematology: Haemoglobin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients. | 78 weeks |
| Number of Patients With Abnormalities in Haematology: Haematocrit | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%. | 78 weeks |
| Number of Patients With Abnormalities in Haematology: Red Blood Cell Count | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L. | 78 weeks |
| Number of Patients With Abnormalities in Haematology: White Blood Cell Count | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Haematology: Platelets | For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Potassium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Amylase | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Creatinine | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Phosphate | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Calcium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Sodium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase). | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Glucose | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Albumin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | 78 weeks |
| Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. | 78 weeks |
| Baseline and week 30 |
| Change in HbA1c From Baseline to Week 42 | Baseline and week 42 |
| Change in HbA1c From Baseline to Week 54 | Baseline and week 54 |
| Change in HbA1c From Baseline to Week 66 | Baseline and week 66 |
| Change in HbA1c From Baseline to Week 78 | Baseline and week 78 |
| Number of Patients With HbA1c<7.0% Over Time | 78 weeks |
| Number of Patients With HbA1c<6.5% Over Time | 78 weeks |
| Number of Patients With Lowered HbA1c by at Least 0.5% Over Time | 78 weeks |
| Change in FPG From Baseline to Week 6 | Baseline and week 6 |
| Change in FPG From Baseline to Week 18 | Baseline and week 18 |
| Change in FPG From Baseline to Week 30 | Baseline and week 30 |
| Change in FPG From Baseline to Week 42 | Baseline and week 42 |
| Change in FPG From Baseline to Week 54 | Baseline and week 54 |
| Change in FPG From Baseline to Week 66 | Baseline and week 66 |
| Change in FPG From Baseline to Week 78 | Baseline and week 78 |
| Spring Valley |
| California |
| United States |
| 1218.40.10001 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States |
| 1218.40.10021 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | United States |
| 1218.40.10010 Boehringer Ingelheim Investigational Site | Hollywood | Florida | United States |
| 1218.40.10011 Boehringer Ingelheim Investigational Site | Miami | Florida | United States |
| 1218.40.10016 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States |
| 1218.40.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | United States |
| 1218.40.10004 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | United States |
| 1218.40.10005 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1218.40.10018 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1218.40.10007 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1218.40.10009 Boehringer Ingelheim Investigational Site | Federal Way | Washington | United States |
| 1218.40.54002 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1218.40.54010 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1218.40.54011 Boehringer Ingelheim Investigational Site | Mendoza | Argentina |
| 1218.40.54015 Boehringer Ingelheim Investigational Site | Parque Velez Sarfield | Argentina |
| 1218.40.43001 Boehringer Ingelheim Investigational Site | Graz | Austria |
| 1218.40.43005 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1218.40.32005 Boehringer Ingelheim Investigational Site | Bruges | Belgium |
| 1218.40.32007 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1218.40.32006 Boehringer Ingelheim Investigational Site | Edegem | Belgium |
| 1218.40.32004 Boehringer Ingelheim Investigational Site | Genk | Belgium |
| 1218.40.32003 Boehringer Ingelheim Investigational Site | Ghent | Belgium |
| 1218.40.32002 Boehringer Ingelheim Investigational Site | Huy | Belgium |
| 1218.40.32001 Boehringer Ingelheim Investigational Site | Liège | Belgium |
| 1218.40.01005 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1218.40.01010 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1218.40.01003 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1218.40.01011 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1218.40.01006 Boehringer Ingelheim Investigational Site | Etobicoke | Ontario | Canada |
| 1218.40.01009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1218.40.01002 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1218.40.01012 Boehringer Ingelheim Investigational Site | Oakville | Ontario | Canada |
| 1218.40.01008 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.40.20005 Boehringer Ingelheim Investigational Site | Strathroy | Ontario | Canada |
| 1218.40.01001 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.40.01004 Boehringer Ingelheim Investigational Site | Montague | Prince Edward Island | Canada |
| 1218.40.01007 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1218.40.86001 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1218.40.86002 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1218.40.86004 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1218.40.86013 Boehringer Ingelheim Investigational Site | Chengdu | China |
| 1218.40.86009 Boehringer Ingelheim Investigational Site | Dalian | China |
| 1218.40.86011 Boehringer Ingelheim Investigational Site | Guangzhou | China |
| 1218.40.86014 Boehringer Ingelheim Investigational Site | Haerbin | China |
| 1218.40.86008 Boehringer Ingelheim Investigational Site | Qingdao | China |
| 1218.40.86015 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1218.40.86010 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1218.40.86007 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 1218.40.86012 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 1218.40.86006 Boehringer Ingelheim Investigational Site | Xi'an | China |
| 1218.40.38605 Boehringer Ingelheim Investigational Site | Krapinske Toplice | Croatia |
| 1218.40.38604 Boehringer Ingelheim Investigational Site | Slavonski Brod | Croatia |
| 1218.40.42004 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1218.40.42007 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1218.40.42009 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1218.40.42006 Boehringer Ingelheim Investigational Site | Břeclav | Czechia |
| 1218.40.42008 Boehringer Ingelheim Investigational Site | Hodonín | Czechia |
| 1218.40.42003 Boehringer Ingelheim Investigational Site | Olomouc | Czechia |
| 1218.40.35806 Boehringer Ingelheim Investigational Site | Helsinki | Finland |
| 1218.40.35801 Boehringer Ingelheim Investigational Site | Kuopio | Finland |
| 1218.40.35803 Boehringer Ingelheim Investigational Site | Oulu | Finland |
| 1218.40.35805 Boehringer Ingelheim Investigational Site | Seinäjoki | Finland |
| 1218.40.35802 Boehringer Ingelheim Investigational Site | Turku | Finland |
| 1218.40.49028 Boehringer Ingelheim Investigational Site | Bad Mergentheim | Germany |
| 1218.40.49022 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1218.40.49024 Boehringer Ingelheim Investigational Site | Bosenheim | Germany |
| 1218.40.49020 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1218.40.49101 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1218.40.49003 Boehringer Ingelheim Investigational Site | Neuwied | Germany |
| 1218.40.49007 Boehringer Ingelheim Investigational Site | Nuremberg | Germany |
| 1218.40.49014 Boehringer Ingelheim Investigational Site | Saarbrücken | Germany |
| 1218.40.30004 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1218.40.30007 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1218.40.30013 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1218.40.30003 Boehringer Ingelheim Investigational Site | Nikaia | Greece |
| 1218.40.30011 Boehringer Ingelheim Investigational Site | Piraeus | Greece |
| 1218.40.30006 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1218.40.30016 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece |
| 1218.40.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.40.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.40.36006 Boehringer Ingelheim Investigational Site | Budapest | Hungary |
| 1218.40.36008 Boehringer Ingelheim Investigational Site | Debrecen | Hungary |
| 1218.40.36005 Boehringer Ingelheim Investigational Site | Győr | Hungary |
| 1218.40.36002 Boehringer Ingelheim Investigational Site | Szombathely | Hungary |
| 1218.40.91010 Boehringer Ingelheim Investigational Site | Andhra Pradesh | India |
| 1218.40.91002 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.40.91005 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.40.91012 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1218.40.91014 Boehringer Ingelheim Investigational Site | Chennai | India |
| 1218.40.91009 Boehringer Ingelheim Investigational Site | Hyderabad, Andra Pradesh | India |
| 1218.40.91006 Boehringer Ingelheim Investigational Site | Jaipur | India |
| 1218.40.91001 Boehringer Ingelheim Investigational Site | Kerala | India |
| 1218.40.91011 Boehringer Ingelheim Investigational Site | Maharashtra | India |
| 1218.40.91008 Boehringer Ingelheim Investigational Site | Mangalore | India |
| 1218.40.91007 Boehringer Ingelheim Investigational Site | Manipal | India |
| 1218.40.91004 Boehringer Ingelheim Investigational Site | Mumbai | India |
| 1218.40.91003 Boehringer Ingelheim Investigational Site | Nashik | India |
| 1218.40.91013 Boehringer Ingelheim Investigational Site | Uttar Pradesh | India |
| 1218.40.97274 Boehringer Ingelheim Investigational Site | Afula | Israel |
| 1218.40.97273 Boehringer Ingelheim Investigational Site | Haifa | Israel |
| 1218.40.97275 Boehringer Ingelheim Investigational Site | Holon | Israel |
| 1218.40.97271 Boehringer Ingelheim Investigational Site | Jerusalem | Israel |
| 1218.40.97272 Boehringer Ingelheim Investigational Site | Nahariya | Israel |
| 1218.40.97276 Boehringer Ingelheim Investigational Site | Safed | Israel |
| 1218.40.97278 Boehringer Ingelheim Investigational Site | Tel Aviv | Israel |
| 1218.40.39008 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1218.40.39002 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1218.40.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1218.40.39006 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1218.40.81001 Boehringer Ingelheim Investigational Site | Amagasaki, Hyogo | Japan |
| 1218.40.81005 Boehringer Ingelheim Investigational Site | Koganei, Tokyo | Japan |
| 1218.40.81002 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1218.40.81004 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1218.40.81003 Boehringer Ingelheim Investigational Site | Suita, Osaka, | Japan |
| 1218.40.60007 Boehringer Ingelheim Investigational Site | George Town | Malaysia |
| 1218.40.60003 Boehringer Ingelheim Investigational Site | Kelantan | Malaysia |
| 1218.40.60001 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1218.40.60002 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia |
| 1218.40.60004 Boehringer Ingelheim Investigational Site | Perak | Malaysia |
| 1218.40.60005 Boehringer Ingelheim Investigational Site | Perak | Malaysia |
| 1218.40.52007 Boehringer Ingelheim Investigational Site | Aguascalientes, Ags. | Mexico |
| 1218.40.52010 Boehringer Ingelheim Investigational Site | Col.Americana, Guadalajara, Jalisco | Mexico |
| 1218.40.52008 Boehringer Ingelheim Investigational Site | Colonia Tlalpan, Mexico | Mexico |
| 1218.40.52006 Boehringer Ingelheim Investigational Site | Faccionamiento Lomas de Campestre,AGUASCAL | Mexico |
| 1218.40.52009 Boehringer Ingelheim Investigational Site | León | Mexico |
| 1218.40.52002 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.40.52004 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.40.52005 Boehringer Ingelheim Investigational Site | México | Mexico |
| 1218.40.52003 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1218.40.52001 Boehringer Ingelheim Investigational Site | Monterrey N.L. | Mexico |
| 1218.40.31006 Boehringer Ingelheim Investigational Site | Deurne | Netherlands |
| 1218.40.31001 Boehringer Ingelheim Investigational Site | Ewijk | Netherlands |
| 1218.40.31010 Boehringer Ingelheim Investigational Site | Losser | Netherlands |
| 1218.40.31008 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands |
| 1218.40.31002 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands |
| 1218.40.64004 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 1218.40.64003 Boehringer Ingelheim Investigational Site | Dunedin | New Zealand |
| 1218.40.64002 Boehringer Ingelheim Investigational Site | Otahuhu | New Zealand |
| 1218.40.64001 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand |
| 1218.40.64005 Boehringer Ingelheim Investigational Site | Wellington | New Zealand |
| 1218.40.63003 Boehringer Ingelheim Investigational Site | Greenhills, San Juan | Philippines |
| 1218.40.63005 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1218.40.63002 Boehringer Ingelheim Investigational Site | Marikina City | Philippines |
| 1218.40.63001 Boehringer Ingelheim Investigational Site | Pasig | Philippines |
| 1218.40.63004 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1218.40.48603 Boehringer Ingelheim Investigational Site | Lublin | Poland |
| 1218.40.48601 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1218.40.48604 Boehringer Ingelheim Investigational Site | Zabrze | Poland |
| 1218.40.40504 Boehringer Ingelheim Investigational Site | Alba Iulia | Romania |
| 1218.40.40604 Boehringer Ingelheim Investigational Site | Brasov | Romania |
| 1218.40.40501 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.40.40502 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1218.40.40603 Boehringer Ingelheim Investigational Site | Galati | Romania |
| 1218.40.40503 Boehringer Ingelheim Investigational Site | Sibiu | Romania |
| 1218.40.40505 Boehringer Ingelheim Investigational Site | Târgu Mureş | Romania |
| 1218.40.70014 Boehringer Ingelheim Investigational Site | Arkhangelsk | Russia |
| 1218.40.70001 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.40.70002 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.40.70003 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.40.70012 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 1218.40.70005 Boehringer Ingelheim Investigational Site | Novosibirsk | Russia |
| 1218.40.70006 Boehringer Ingelheim Investigational Site | Perm | Russia |
| 1218.40.70013 Boehringer Ingelheim Investigational Site | Rostov-on-Don | Russia |
| 1218.40.70015 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1218.40.70016 Boehringer Ingelheim Investigational Site | Samara | Russia |
| 1218.40.70004 Boehringer Ingelheim Investigational Site | Tomsk | Russia |
| 1218.40.42103 Boehringer Ingelheim Investigational Site | Banská Bystrica | Slovakia |
| 1218.40.42102 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.40.42104 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.40.42105 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia |
| 1218.40.42101 Boehringer Ingelheim Investigational Site | Nové Mesto | Slovakia |
| 1218.40.42106 Boehringer Ingelheim Investigational Site | Šamorín | Slovakia |
| 1218.40.82002 Boehringer Ingelheim Investigational Site | Busan | South Korea |
| 1218.40.82011 Boehringer Ingelheim Investigational Site | Daegu | South Korea |
| 1218.40.82008 Boehringer Ingelheim Investigational Site | Incheon | South Korea |
| 1218.40.82010 Boehringer Ingelheim Investigational Site | Jeonju | South Korea |
| 1218.40.82004 Boehringer Ingelheim Investigational Site | Pusan | South Korea |
| 1218.40.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.40.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.40.82006 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.40.82007 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.40.82009 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1218.40.82003 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1218.40.34002 Boehringer Ingelheim Investigational Site | Badalona | Spain |
| 1218.40.34011 Boehringer Ingelheim Investigational Site | Badia Del Vallés | Spain |
| 1218.40.34012 Boehringer Ingelheim Investigational Site | Borges Del Camp | Spain |
| 1218.40.34013 Boehringer Ingelheim Investigational Site | Centelles | Spain |
| 1218.40.34007 Boehringer Ingelheim Investigational Site | Granada | Spain |
| 1218.40.34008 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1218.40.34009 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain |
| 1218.40.34004 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.40.34006 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1218.40.34010 Boehringer Ingelheim Investigational Site | Sant Adrià Del Besós (Barcelona) | Spain |
| 1218.40.34005 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1218.40.34014 Boehringer Ingelheim Investigational Site | Vic (Barcelona) | Spain |
| 1218.40.46013 Boehringer Ingelheim Investigational Site | Härnösand | Sweden |
| 1218.40.46001 Boehringer Ingelheim Investigational Site | Malmö | Sweden |
| 1218.40.46012 Boehringer Ingelheim Investigational Site | Uddevalla | Sweden |
| 1218.40.46004 Boehringer Ingelheim Investigational Site | Uppsala | Sweden |
| 1218.40.88605 Boehringer Ingelheim Investigational Site | Changhua | Taiwan |
| 1218.40.88604 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1218.40.88606 Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| 1218.40.88601 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1218.40.88602 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1218.40.88603 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1218.40.88607 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1218.40.88608 Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan |
| 1218.40.66001 Boehringer Ingelheim Investigational Site | Bangkok | Thailand |
| 1218.40.66002 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand |
| 1218.40.38011 Boehringer Ingelheim Investigational Site | Dnipro | Ukraine |
| 1218.40.38002 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.40.38004 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.40.38010 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 1218.40.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.40.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.40.38008 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.40.38009 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.40.38012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 1218.40.38003 Boehringer Ingelheim Investigational Site | Lviv | Ukraine |
| 1218.40.38006 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine |
| 1218.40.38007 Boehringer Ingelheim Investigational Site | Zaporizhzhya | Ukraine |
| 1218.40.44005 Boehringer Ingelheim Investigational Site | Ashford | United Kingdom |
| 1218.40.44004 Boehringer Ingelheim Investigational Site | Baillieston, Glasgow | United Kingdom |
| 1218.40.44001 Boehringer Ingelheim Investigational Site | Bath | United Kingdom |
| 1218.40.44003 Boehringer Ingelheim Investigational Site | Burbage | United Kingdom |
| 1218.40.44010 Boehringer Ingelheim Investigational Site | Bury Saint Edmonds | United Kingdom |
| 1218.40.44009 Boehringer Ingelheim Investigational Site | Cardiff | United Kingdom |
| 1218.40.44002 Boehringer Ingelheim Investigational Site | Penarth | United Kingdom |
| 1218.40.44006 Boehringer Ingelheim Investigational Site | Reading | United Kingdom |
| 1218.40.44007 Boehringer Ingelheim Investigational Site | Waterloo, Liverpool | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Old Lina | Patients pre-treated with linagliptin |
| BG001 | New Lina | Patients pre-treated with placebo |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) continuous | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Baseline weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Baseline Glycosylated haemoglobin (HbA1c) at baseline | Mean | Standard Deviation | percent |
| |||||||||||||||
| Fasting plasma glucose (FPG) at baseline | 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 | Frequency of Patients With Adverse Events (AEs) | This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures. | Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. | Posted | Number | Participants | 78 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events | Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. | Posted | Number | Participants | 78 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ) | As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis''). | Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events | Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC) | Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Vital Signs | Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events) | Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: Eosinophils | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%. | Treated Set with values for Eosinophils | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: Haemoglobin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients. | Treated Set with values for Haemoglobin | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: Haematocrit | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%. | Treated Set with values for Haematocrit | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: Red Blood Cell Count | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L. | Treated Set with values for Red blood cell count | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: White Blood Cell Count | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase). | Treated Set with values for White blood cell count | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Haematology: Platelets | For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase). | Treated Set with values for Platelets | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Potassium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase). | Treated Set with values for Potassium | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients. | Treated Set with values for Uric acid | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. | Treated Set with values for Triglycerides | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Amylase | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN). | Treated Set with values for Amylase | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | Treated Set with values for GGT | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL. | Treated Set with values for Creatinine | Posted | Number | Participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | Treated Set with values for Creatinine kinase | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Phosphate | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase). | Treated Set with values for Phosphate | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Calcium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase). | Treated Set with values for Calcium | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Sodium | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase). | Treated Set with values for Sodium | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | Treated Set with values for ALT | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | Treated Set with values for AST | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Glucose | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL. | Treated Set with values for Glucose | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL. | Treated Set with values for Bilirubin | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN. | Treated Set with values for AP | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Albumin | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL. | Treated Set with values for Albumin | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH) | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. | Treated Set with values for LDH | Posted | Number | participants | 78 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 6 | Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 18 | Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 30 | Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 30 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 42 | Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 42 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 54 | Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 54 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 66 | Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 66 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 78 | Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | percent | Baseline and week 78 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With HbA1c<7.0% Over Time | Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. | Posted | Number | participants | 78 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With HbA1c<6.5% Over Time | Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. | Posted | Number | participants | 78 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Lowered HbA1c by at Least 0.5% Over Time | Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. | Posted | Number | participants | 78 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 6 | Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 6 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 18 | Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 18 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 30 | Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 30 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 42 | Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 42 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 54 | Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 54 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 66 | Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 66 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 78 | Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing. | Posted | Mean | Standard Deviation | mg/dL | Baseline and week 78 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. | Treated Set with values for Cholesterol | Posted | Number | participants | 78 weeks |
|
|
78 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 | Old Lina | Patients pre-treated with linagliptin | 158 | 1,532 | 784 | 1,532 | ||
| EG001 | New Lina | Patients pre-treated with placebo | 52 | 589 | 285 | 589 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dolichocolon | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peritoneal cyst | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vaccination site hypersensitivity | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Polyarteritis nodosa | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Campylobacter intestinal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Chikungunya virus infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Peritoneal infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bone sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Tonsillar neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cervical myelopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nerve root compression | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cervical polyp | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fallopian tube cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intra-uterine contraceptive device removal | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Other - 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 |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Patients with withdrawal due to AEs (from AE page) |
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