Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00736099
Collaborator
(none)
2,122
232
2
9.1
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2122 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.
Study Start Date
:
Aug 1, 2008
Actual Primary Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: linagliptin 5 mg open label |
Drug: linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label
|
| Experimental: linagliptin 5 mg and pioglitazone 30 mg open label |
Drug: linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone
|
Outcome Measures
Primary Outcome Measures
- Frequency of Patients With Adverse Events (AEs) [78 weeks]
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
- Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events [78 weeks]
- Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ) [78 weeks]
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'').
- Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events [78 weeks]
Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
- Number of Patients With Abnormalities in Vital Signs [78 weeks]
Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
- Number of Patients With Abnormalities in Haematology: Eosinophils [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
- Number of Patients With Abnormalities in Haematology: Haemoglobin [78 weeks]
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.
- Number of Patients With Abnormalities in Haematology: Haematocrit [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
- Number of Patients With Abnormalities in Haematology: Red Blood Cell Count [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.
- Number of Patients With Abnormalities in Haematology: White Blood Cell Count [78 weeks]
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).
- Number of Patients With Abnormalities in Haematology: Platelets [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: Potassium [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid [78 weeks]
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.
- Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
- Number of Patients With Abnormalities in Clinical Chemistry: Amylase [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT) [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Creatinine [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
- Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Phosphate [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: Calcium [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: Sodium [78 weeks]
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).
- Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT) [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST) [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Glucose [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
- Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
- Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP) [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Albumin [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
- Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH) [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
- Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol [78 weeks]
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
Secondary Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 82 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Signed and dated written informed consent in accordance with the GCP and local legislation.
-
Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.
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:
-
are nursing or pregnant,
-
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1218.40.10003 Boehringer Ingelheim Investigational Site | Chula Vista | California | United States | |
| 2 | 1218.40.10014 Boehringer Ingelheim Investigational Site | Spring Valley | California | United States | |
| 3 | 1218.40.10001 Boehringer Ingelheim Investigational Site | Walnut Creek | California | United States | |
| 4 | 1218.40.10021 Boehringer Ingelheim Investigational Site | Northglenn | Colorado | United States | |
| 5 | 1218.40.10010 Boehringer Ingelheim Investigational Site | Hollywood | Florida | United States | |
| 6 | 1218.40.10011 Boehringer Ingelheim Investigational Site | Miami | Florida | United States | |
| 7 | 1218.40.10016 Boehringer Ingelheim Investigational Site | Eugene | Oregon | United States | |
| 8 | 1218.40.10002 Boehringer Ingelheim Investigational Site | Greer | South Carolina | United States | |
| 9 | 1218.40.10004 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina | United States | |
| 10 | 1218.40.10005 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 11 | 1218.40.10018 Boehringer Ingelheim Investigational Site | Houston | Texas | United States | |
| 12 | 1218.40.10007 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States | |
| 13 | 1218.40.10009 Boehringer Ingelheim Investigational Site | Federal Way | Washington | United States | |
| 14 | 1218.40.54002 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 15 | 1218.40.54010 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina | ||
| 16 | 1218.40.54011 Boehringer Ingelheim Investigational Site | Mendoza | Argentina | ||
| 17 | 1218.40.54015 Boehringer Ingelheim Investigational Site | Parque Velez Sarfield | Argentina | ||
| 18 | 1218.40.43001 Boehringer Ingelheim Investigational Site | Graz | Austria | ||
| 19 | 1218.40.43005 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 20 | 1218.40.32005 Boehringer Ingelheim Investigational Site | Brugge | Belgium | ||
| 21 | 1218.40.32007 Boehringer Ingelheim Investigational Site | Brussel | Belgium | ||
| 22 | 1218.40.32006 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 23 | 1218.40.32004 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||
| 24 | 1218.40.32003 Boehringer Ingelheim Investigational Site | Gent | Belgium | ||
| 25 | 1218.40.32002 Boehringer Ingelheim Investigational Site | Huy | Belgium | ||
| 26 | 1218.40.32001 Boehringer Ingelheim Investigational Site | Liège | Belgium | ||
| 27 | 1218.40.01005 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 28 | 1218.40.01010 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 29 | 1218.40.01003 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 30 | 1218.40.01011 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 31 | 1218.40.01006 Boehringer Ingelheim Investigational Site | Etobicoke | Ontario | Canada | |
| 32 | 1218.40.01009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada | |
| 33 | 1218.40.01002 Boehringer Ingelheim Investigational Site | London | Ontario | Canada | |
| 34 | 1218.40.01012 Boehringer Ingelheim Investigational Site | Oakville | Ontario | Canada | |
| 35 | 1218.40.01008 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada | |
| 36 | 1218.40.20005 Boehringer Ingelheim Investigational Site | Strathroy | Ontario | Canada | |
| 37 | 1218.40.01001 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada | |
| 38 | 1218.40.01004 Boehringer Ingelheim Investigational Site | Montague | Prince Edward Island | Canada | |
| 39 | 1218.40.01007 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada | |
| 40 | 1218.40.86001 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 41 | 1218.40.86002 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 42 | 1218.40.86004 Boehringer Ingelheim Investigational Site | Beijing | China | ||
| 43 | 1218.40.86013 Boehringer Ingelheim Investigational Site | Chengdu | China | ||
| 44 | 1218.40.86009 Boehringer Ingelheim Investigational Site | Dalian | China | ||
| 45 | 1218.40.86011 Boehringer Ingelheim Investigational Site | Guangzhou | China | ||
| 46 | 1218.40.86014 Boehringer Ingelheim Investigational Site | Haerbin | China | ||
| 47 | 1218.40.86008 Boehringer Ingelheim Investigational Site | Qingdao | China | ||
| 48 | 1218.40.86015 Boehringer Ingelheim Investigational Site | Shanghai | China | ||
| 49 | 1218.40.86010 Boehringer Ingelheim Investigational Site | Shenyang | China | ||
| 50 | 1218.40.86007 Boehringer Ingelheim Investigational Site | Wuhan | China | ||
| 51 | 1218.40.86012 Boehringer Ingelheim Investigational Site | Wuhan | China | ||
| 52 | 1218.40.86006 Boehringer Ingelheim Investigational Site | Xi'An | China | ||
| 53 | 1218.40.38605 Boehringer Ingelheim Investigational Site | Krapinske Toplice | Croatia | ||
| 54 | 1218.40.38604 Boehringer Ingelheim Investigational Site | Slavonski Brod | Croatia | ||
| 55 | 1218.40.42006 Boehringer Ingelheim Investigational Site | Breclav | Czech Republic | ||
| 56 | 1218.40.42004 Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 57 | 1218.40.42007 Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 58 | 1218.40.42009 Boehringer Ingelheim Investigational Site | Brno | Czech Republic | ||
| 59 | 1218.40.42008 Boehringer Ingelheim Investigational Site | Hodonin | Czech Republic | ||
| 60 | 1218.40.42003 Boehringer Ingelheim Investigational Site | Olomouc | Czech Republic | ||
| 61 | 1218.40.35806 Boehringer Ingelheim Investigational Site | Helsinki | Finland | ||
| 62 | 1218.40.35801 Boehringer Ingelheim Investigational Site | Kuopio | Finland | ||
| 63 | 1218.40.35803 Boehringer Ingelheim Investigational Site | Oulu | Finland | ||
| 64 | 1218.40.35805 Boehringer Ingelheim Investigational Site | Seinäjoki | Finland | ||
| 65 | 1218.40.35802 Boehringer Ingelheim Investigational Site | Turku | Finland | ||
| 66 | 1218.40.49028 Boehringer Ingelheim Investigational Site | Bad Mergentheim | Germany | ||
| 67 | 1218.40.49022 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 68 | 1218.40.49024 Boehringer Ingelheim Investigational Site | Bosenheim | Germany | ||
| 69 | 1218.40.49020 Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 70 | 1218.40.49101 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 71 | 1218.40.49003 Boehringer Ingelheim Investigational Site | Neuwied | Germany | ||
| 72 | 1218.40.49007 Boehringer Ingelheim Investigational Site | Nürnberg | Germany | ||
| 73 | 1218.40.49014 Boehringer Ingelheim Investigational Site | Saarbrücken | Germany | ||
| 74 | 1218.40.30004 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 75 | 1218.40.30007 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 76 | 1218.40.30013 Boehringer Ingelheim Investigational Site | Athens | Greece | ||
| 77 | 1218.40.30003 Boehringer Ingelheim Investigational Site | Nikaia | Greece | ||
| 78 | 1218.40.30011 Boehringer Ingelheim Investigational Site | Piraeus | Greece | ||
| 79 | 1218.40.30006 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 80 | 1218.40.30016 Boehringer Ingelheim Investigational Site | Thessaloniki | Greece | ||
| 81 | 1218.40.36003 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 82 | 1218.40.36004 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 83 | 1218.40.36006 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 84 | 1218.40.36008 Boehringer Ingelheim Investigational Site | Debrecen | Hungary | ||
| 85 | 1218.40.36005 Boehringer Ingelheim Investigational Site | Györ | Hungary | ||
| 86 | 1218.40.36002 Boehringer Ingelheim Investigational Site | Szombathely | Hungary | ||
| 87 | 1218.40.91010 Boehringer Ingelheim Investigational Site | Andhra Pradesh | India | ||
| 88 | 1218.40.91002 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 89 | 1218.40.91005 Boehringer Ingelheim Investigational Site | Bangalore | India | ||
| 90 | 1218.40.91012 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 91 | 1218.40.91014 Boehringer Ingelheim Investigational Site | Chennai | India | ||
| 92 | 1218.40.91009 Boehringer Ingelheim Investigational Site | Hyderabad, Andra Pradesh | India | ||
| 93 | 1218.40.91006 Boehringer Ingelheim Investigational Site | Jaipur | India | ||
| 94 | 1218.40.91001 Boehringer Ingelheim Investigational Site | Kerala | India | ||
| 95 | 1218.40.91011 Boehringer Ingelheim Investigational Site | Maharashtra | India | ||
| 96 | 1218.40.91008 Boehringer Ingelheim Investigational Site | Mangalore | India | ||
| 97 | 1218.40.91007 Boehringer Ingelheim Investigational Site | Manipal | India | ||
| 98 | 1218.40.91004 Boehringer Ingelheim Investigational Site | Mumbai | India | ||
| 99 | 1218.40.91003 Boehringer Ingelheim Investigational Site | Nasik | India | ||
| 100 | 1218.40.91013 Boehringer Ingelheim Investigational Site | Uttar Pradesh | India | ||
| 101 | 1218.40.97274 Boehringer Ingelheim Investigational Site | Afula | Israel | ||
| 102 | 1218.40.97273 Boehringer Ingelheim Investigational Site | Haifa | Israel | ||
| 103 | 1218.40.97275 Boehringer Ingelheim Investigational Site | Holon | Israel | ||
| 104 | 1218.40.97271 Boehringer Ingelheim Investigational Site | Jerusalem | Israel | ||
| 105 | 1218.40.97272 Boehringer Ingelheim Investigational Site | Nahariya | Israel | ||
| 106 | 1218.40.97276 Boehringer Ingelheim Investigational Site | Safed | Israel | ||
| 107 | 1218.40.97278 Boehringer Ingelheim Investigational Site | Tel Aviv | Israel | ||
| 108 | 1218.40.39008 Boehringer Ingelheim Investigational Site | Genova | Italy | ||
| 109 | 1218.40.39002 Boehringer Ingelheim Investigational Site | Milano | Italy | ||
| 110 | 1218.40.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy | ||
| 111 | 1218.40.39006 Boehringer Ingelheim Investigational Site | Roma | Italy | ||
| 112 | 1218.40.81001 Boehringer Ingelheim Investigational Site | Amagasaki, Hyogo | Japan | ||
| 113 | 1218.40.81005 Boehringer Ingelheim Investigational Site | Koganei, Tokyo | Japan | ||
| 114 | 1218.40.81002 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan | ||
| 115 | 1218.40.81004 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan | ||
| 116 | 1218.40.81003 Boehringer Ingelheim Investigational Site | Suita, Osaka, | Japan | ||
| 117 | 1218.40.82002 Boehringer Ingelheim Investigational Site | Busan | Korea, Republic of | ||
| 118 | 1218.40.82011 Boehringer Ingelheim Investigational Site | Daegu | Korea, Republic of | ||
| 119 | 1218.40.82008 Boehringer Ingelheim Investigational Site | Incheon | Korea, Republic of | ||
| 120 | 1218.40.82010 Boehringer Ingelheim Investigational Site | Jeonju | Korea, Republic of | ||
| 121 | 1218.40.82004 Boehringer Ingelheim Investigational Site | Pusan | Korea, Republic of | ||
| 122 | 1218.40.82001 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 123 | 1218.40.82005 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 124 | 1218.40.82006 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 125 | 1218.40.82007 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 126 | 1218.40.82009 Boehringer Ingelheim Investigational Site | Seoul | Korea, Republic of | ||
| 127 | 1218.40.82003 Boehringer Ingelheim Investigational Site | Suwon | Korea, Republic of | ||
| 128 | 1218.40.60003 Boehringer Ingelheim Investigational Site | Kelantan | Malaysia | ||
| 129 | 1218.40.60001 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 130 | 1218.40.60002 Boehringer Ingelheim Investigational Site | Kuala Lumpur | Malaysia | ||
| 131 | 1218.40.60007 Boehringer Ingelheim Investigational Site | Penang | Malaysia | ||
| 132 | 1218.40.60004 Boehringer Ingelheim Investigational Site | Perak | Malaysia | ||
| 133 | 1218.40.60005 Boehringer Ingelheim Investigational Site | Perak | Malaysia | ||
| 134 | 1218.40.52007 Boehringer Ingelheim Investigational Site | Aguascalientes, Ags. | Mexico | ||
| 135 | 1218.40.52010 Boehringer Ingelheim Investigational Site | Col.Americana, Guadalajara, Jalisco | Mexico | ||
| 136 | 1218.40.52008 Boehringer Ingelheim Investigational Site | Colonia Tlalpan, mexico | Mexico | ||
| 137 | 1218.40.52006 Boehringer Ingelheim Investigational Site | Faccionamiento Lomas de Campestre,AGUASCAL | Mexico | ||
| 138 | 1218.40.52009 Boehringer Ingelheim Investigational Site | León | Mexico | ||
| 139 | 1218.40.52001 Boehringer Ingelheim Investigational Site | Monterrey N.L. | Mexico | ||
| 140 | 1218.40.52003 Boehringer Ingelheim Investigational Site | Monterrey | Mexico | ||
| 141 | 1218.40.52002 Boehringer Ingelheim Investigational Site | México | Mexico | ||
| 142 | 1218.40.52004 Boehringer Ingelheim Investigational Site | México | Mexico | ||
| 143 | 1218.40.52005 Boehringer Ingelheim Investigational Site | México | Mexico | ||
| 144 | 1218.40.31006 Boehringer Ingelheim Investigational Site | Deurne | Netherlands | ||
| 145 | 1218.40.31001 Boehringer Ingelheim Investigational Site | Ewijk | Netherlands | ||
| 146 | 1218.40.31010 Boehringer Ingelheim Investigational Site | Losser | Netherlands | ||
| 147 | 1218.40.31008 Boehringer Ingelheim Investigational Site | Roelofarendsveen | Netherlands | ||
| 148 | 1218.40.31002 Boehringer Ingelheim Investigational Site | Wildervank | Netherlands | ||
| 149 | 1218.40.64004 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand | ||
| 150 | 1218.40.64003 Boehringer Ingelheim Investigational Site | Dunedin | New Zealand | ||
| 151 | 1218.40.64002 Boehringer Ingelheim Investigational Site | Otahuhu | New Zealand | ||
| 152 | 1218.40.64001 Boehringer Ingelheim Investigational Site | Tauranga | New Zealand | ||
| 153 | 1218.40.64005 Boehringer Ingelheim Investigational Site | Wellington | New Zealand | ||
| 154 | 1218.40.63003 Boehringer Ingelheim Investigational Site | Greenhills, San Juan | Philippines | ||
| 155 | 1218.40.63005 Boehringer Ingelheim Investigational Site | Manila | Philippines | ||
| 156 | 1218.40.63002 Boehringer Ingelheim Investigational Site | Marikina | Philippines | ||
| 157 | 1218.40.63001 Boehringer Ingelheim Investigational Site | Pasig | Philippines | ||
| 158 | 1218.40.63004 Boehringer Ingelheim Investigational Site | Quezon City | Philippines | ||
| 159 | 1218.40.48603 Boehringer Ingelheim Investigational Site | Lublin | Poland | ||
| 160 | 1218.40.48601 Boehringer Ingelheim Investigational Site | Warsaw | Poland | ||
| 161 | 1218.40.48604 Boehringer Ingelheim Investigational Site | Zabrze | Poland | ||
| 162 | 1218.40.40504 Boehringer Ingelheim Investigational Site | Alba Iulia | Romania | ||
| 163 | 1218.40.40604 Boehringer Ingelheim Investigational Site | Brasov | Romania | ||
| 164 | 1218.40.40501 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 165 | 1218.40.40502 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 166 | 1218.40.40603 Boehringer Ingelheim Investigational Site | Galati | Romania | ||
| 167 | 1218.40.40503 Boehringer Ingelheim Investigational Site | Sibiu | Romania | ||
| 168 | 1218.40.40505 Boehringer Ingelheim Investigational Site | Targu-Mures | Romania | ||
| 169 | 1218.40.70014 Boehringer Ingelheim Investigational Site | Arkhangelsk | Russian Federation | ||
| 170 | 1218.40.70001 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 171 | 1218.40.70002 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 172 | 1218.40.70003 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 173 | 1218.40.70012 Boehringer Ingelheim Investigational Site | Moscow | Russian Federation | ||
| 174 | 1218.40.70005 Boehringer Ingelheim Investigational Site | Novosibirsk | Russian Federation | ||
| 175 | 1218.40.70006 Boehringer Ingelheim Investigational Site | Perm | Russian Federation | ||
| 176 | 1218.40.70013 Boehringer Ingelheim Investigational Site | Rostov-on-Don | Russian Federation | ||
| 177 | 1218.40.70016 Boehringer Ingelheim Investigational Site | Samara | Russian Federation | ||
| 178 | 1218.40.70015 Boehringer Ingelheim Investigational Site | St. Petersburg | Russian Federation | ||
| 179 | 1218.40.70004 Boehringer Ingelheim Investigational Site | Tomsk | Russian Federation | ||
| 180 | 1218.40.42103 Boehringer Ingelheim Investigational Site | Banska Bystrica | Slovakia | ||
| 181 | 1218.40.42102 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 182 | 1218.40.42104 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 183 | 1218.40.42105 Boehringer Ingelheim Investigational Site | Bratislava | Slovakia | ||
| 184 | 1218.40.42101 Boehringer Ingelheim Investigational Site | Nove Mesto | Slovakia | ||
| 185 | 1218.40.42106 Boehringer Ingelheim Investigational Site | Samorin | Slovakia | ||
| 186 | 1218.40.34002 Boehringer Ingelheim Investigational Site | Badalona | Spain | ||
| 187 | 1218.40.34011 Boehringer Ingelheim Investigational Site | Badia del Vallés | Spain | ||
| 188 | 1218.40.34012 Boehringer Ingelheim Investigational Site | Borges del Camp | Spain | ||
| 189 | 1218.40.34013 Boehringer Ingelheim Investigational Site | Centelles | Spain | ||
| 190 | 1218.40.34007 Boehringer Ingelheim Investigational Site | Granada | Spain | ||
| 191 | 1218.40.34008 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain | ||
| 192 | 1218.40.34009 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat (Barcelona) | Spain | ||
| 193 | 1218.40.34004 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 194 | 1218.40.34006 Boehringer Ingelheim Investigational Site | Madrid | Spain | ||
| 195 | 1218.40.34010 Boehringer Ingelheim Investigational Site | Sant Adrià del Besós (Barcelona) | Spain | ||
| 196 | 1218.40.34005 Boehringer Ingelheim Investigational Site | Sevilla | Spain | ||
| 197 | 1218.40.34014 Boehringer Ingelheim Investigational Site | Vic (Barcelona) | Spain | ||
| 198 | 1218.40.46013 Boehringer Ingelheim Investigational Site | Härnösand | Sweden | ||
| 199 | 1218.40.46001 Boehringer Ingelheim Investigational Site | Malmö | Sweden | ||
| 200 | 1218.40.46012 Boehringer Ingelheim Investigational Site | Uddevalla | Sweden | ||
| 201 | 1218.40.46004 Boehringer Ingelheim Investigational Site | Uppsala | Sweden | ||
| 202 | 1218.40.88605 Boehringer Ingelheim Investigational Site | ChangHua | Taiwan | ||
| 203 | 1218.40.88604 Boehringer Ingelheim Investigational Site | Taichung | Taiwan | ||
| 204 | 1218.40.88606 Boehringer Ingelheim Investigational Site | Tainan | Taiwan | ||
| 205 | 1218.40.88601 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 206 | 1218.40.88602 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 207 | 1218.40.88603 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 208 | 1218.40.88607 Boehringer Ingelheim Investigational Site | Taipei | Taiwan | ||
| 209 | 1218.40.88608 Boehringer Ingelheim Investigational Site | Taoyuan | Taiwan | ||
| 210 | 1218.40.66001 Boehringer Ingelheim Investigational Site | Bangkok | Thailand | ||
| 211 | 1218.40.66002 Boehringer Ingelheim Investigational Site | Khon Kaen | Thailand | ||
| 212 | 1218.40.38011 Boehringer Ingelheim Investigational Site | Dnepropetrovsk | Ukraine | ||
| 213 | 1218.40.38002 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 214 | 1218.40.38004 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 215 | 1218.40.38010 Boehringer Ingelheim Investigational Site | Kharkov | Ukraine | ||
| 216 | 1218.40.38001 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 217 | 1218.40.38005 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 218 | 1218.40.38008 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 219 | 1218.40.38009 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 220 | 1218.40.38012 Boehringer Ingelheim Investigational Site | Kiev | Ukraine | ||
| 221 | 1218.40.38003 Boehringer Ingelheim Investigational Site | Lvov | Ukraine | ||
| 222 | 1218.40.38006 Boehringer Ingelheim Investigational Site | Vinnitsa | Ukraine | ||
| 223 | 1218.40.38007 Boehringer Ingelheim Investigational Site | Zaporizhzhya | Ukraine | ||
| 224 | 1218.40.44005 Boehringer Ingelheim Investigational Site | Ashford | United Kingdom | ||
| 225 | 1218.40.44004 Boehringer Ingelheim Investigational Site | Baillieston, Glasgow | United Kingdom | ||
| 226 | 1218.40.44001 Boehringer Ingelheim Investigational Site | Bath | United Kingdom | ||
| 227 | 1218.40.44003 Boehringer Ingelheim Investigational Site | Burbage | United Kingdom | ||
| 228 | 1218.40.44010 Boehringer Ingelheim Investigational Site | Bury St Edmonds | United Kingdom | ||
| 229 | 1218.40.44009 Boehringer Ingelheim Investigational Site | Cardiff | United Kingdom | ||
| 230 | 1218.40.44002 Boehringer Ingelheim Investigational Site | Penarth | United Kingdom | ||
| 231 | 1218.40.44006 Boehringer Ingelheim Investigational Site | Reading | United Kingdom | ||
| 232 | 1218.40.44007 Boehringer Ingelheim Investigational Site | Waterloo, Liverpool | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00736099
Other Study ID Numbers:
- 1218.40
- 2008-000750-13
First Posted:
Aug 15, 2008
Last Update Posted:
Jun 27, 2014
Last Verified:
Dec 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin (BI 1356) | Patients pre-treated with placebo |
| Period Title: Overall Study | ||
| STARTED | 1532 | 589 |
| COMPLETED | 1349 | 531 |
| NOT COMPLETED | 183 | 58 |
Baseline Characteristics
| Arm/Group Title | Old Lina | New Lina | Total |
|---|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo | Total of all reporting groups |
| Overall Participants | 1532 | 589 | 2121 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57.8
(9.8)
|
56.7
(10.0)
|
57.5
(9.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
743
48.5%
|
279
47.4%
|
1022
48.2%
|
| Male |
789
51.5%
|
310
52.6%
|
1099
51.8%
|
| Body mass index (BMI) continuous (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
28.86
(4.82)
|
29.18
(4.91)
|
28.95
(4.85)
|
| Baseline weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
78.7
(16.9)
|
80.1
(16.9)
|
79.1
(16.9)
|
| Baseline Glycosylated haemoglobin (HbA1c) at baseline (percent) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percent] |
7.38
(0.90)
|
7.87
(1.04)
|
7.51
(0.97)
|
| Fasting plasma glucose (FPG) at baseline (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
151.59
(35.32)
|
164.31
(37.36)
|
155.12
(36.34)
|
Outcome Measures
| Title | Frequency of Patients With Adverse Events (AEs) |
|---|---|
| Description | This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1532 | 589 |
| Patients with any AEs |
1253
81.8%
|
465
78.9%
|
| Patients with severe AEs |
57
3.7%
|
23
3.9%
|
| Patients with withdrawal due to AEs (from AE page) |
57
3.7%
|
16
2.7%
|
| Title | Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events |
|---|---|
| Description | |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1532 | 589 |
| Number [Participants] |
209
13.6%
|
86
14.6%
|
| Title | Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ) |
|---|---|
| Description | 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''). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1532 | 589 |
| Renal AEs |
20
1.3%
|
10
1.7%
|
| Hypersensitivity reactions |
7
0.5%
|
3
0.5%
|
| Hepatic AEs |
21
1.4%
|
5
0.8%
|
| Severe cutaneous adverse reactions |
0
0%
|
0
0%
|
| Pancreatitis |
4
0.3%
|
0
0%
|
| Title | Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events |
|---|---|
| Description | Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC) |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1532 | 589 |
| Number [participants] |
82
5.4%
|
37
6.3%
|
| Title | Number of Patients With Abnormalities in Vital Signs |
|---|---|
| Description | Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events) |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1532 | 589 |
| Number [Participants] |
0
0%
|
0
0%
|
| Title | Number of Patients With Abnormalities in Haematology: Eosinophils |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Eosinophils |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1512 | 579 |
| Number [participants] |
91
5.9%
|
33
5.6%
|
| Title | Number of Patients With Abnormalities in Haematology: Haemoglobin |
|---|---|
| Description | 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. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Haemoglobin |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1513 | 579 |
| Number [Participants] |
63
4.1%
|
31
5.3%
|
| Title | Number of Patients With Abnormalities in Haematology: Haematocrit |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Haematocrit |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1513 | 579 |
| Number [Participants] |
48
3.1%
|
22
3.7%
|
| Title | Number of Patients With Abnormalities in Haematology: Red Blood Cell Count |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Red blood cell count |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1513 | 579 |
| Number [Participants] |
31
2%
|
13
2.2%
|
| Title | Number of Patients With Abnormalities in Haematology: White Blood Cell Count |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for White blood cell count |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1513 | 579 |
| Decrease |
30
2%
|
10
1.7%
|
| Increase |
1
0.1%
|
1
0.2%
|
| Title | Number of Patients With Abnormalities in Haematology: Platelets |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Platelets |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1513 | 579 |
| Decrease |
5
0.3%
|
0
0%
|
| Increase |
0
0%
|
0
0%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Potassium |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Potassium |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Decrease |
3
0.2%
|
0
0%
|
| Increase |
135
8.8%
|
50
8.5%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid |
|---|---|
| Description | 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. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Uric acid |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [Participants] |
124
8.1%
|
48
8.1%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Triglycerides |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [Participants] |
329
21.5%
|
101
17.1%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Amylase |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Amylase |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [Participants] |
92
6%
|
35
5.9%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT) |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for GGT |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [Participants] |
54
3.5%
|
14
2.4%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Creatinine |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [Participants] |
52
3.4%
|
18
3.1%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Creatinine kinase |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
49
3.2%
|
6
1%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Phosphate |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Phosphate |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Decrease |
11
0.7%
|
8
1.4%
|
| Increase |
38
2.5%
|
11
1.9%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Calcium |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Calcium |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Decrease |
36
2.3%
|
12
2%
|
| Increase |
4
0.3%
|
0
0%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Sodium |
|---|---|
| Description | 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). |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Sodium |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Decrease |
16
1%
|
3
0.5%
|
| Increase |
13
0.8%
|
8
1.4%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT) |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for ALT |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1511 | 578 |
| Number [participants] |
22
1.4%
|
5
0.8%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST) |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for AST |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1511 | 578 |
| Number [participants] |
19
1.2%
|
3
0.5%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Glucose |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Glucose |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
7
0.5%
|
1
0.2%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Bilirubin |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
6
0.4%
|
3
0.5%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP) |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for AP |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
7
0.5%
|
0
0%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Albumin |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Albumin |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
3
0.2%
|
1
0.2%
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH) |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for LDH |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1511 | 577 |
| Number [participants] |
1
0.1%
|
0
0%
|
| Title | Change in HbA1c From Baseline to Week 6 |
|---|---|
| Description | |
| Time Frame | Baseline and week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1401 | 530 |
| Mean (Standard Deviation) [percent] |
-0.02
(0.47)
|
-0.46
(0.51)
|
| Title | Change in HbA1c From Baseline to Week 18 |
|---|---|
| Description | |
| Time Frame | Baseline and week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1302 | 510 |
| Mean (Standard Deviation) [percent] |
0.03
(0.63)
|
-0.63
(0.72)
|
| Title | Change in HbA1c From Baseline to Week 30 |
|---|---|
| Description | |
| Time Frame | Baseline and week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1183 | 469 |
| Mean (Standard Deviation) [percent] |
0.06
(0.71)
|
-0.60
(0.78)
|
| Title | Change in HbA1c From Baseline to Week 42 |
|---|---|
| Description | |
| Time Frame | Baseline and week 42 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1091 | 440 |
| Mean (Standard Deviation) [percent] |
0.13
(0.65)
|
-0.53
(0.78)
|
| Title | Change in HbA1c From Baseline to Week 54 |
|---|---|
| Description | |
| Time Frame | Baseline and week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1008 | 417 |
| Mean (Standard Deviation) [percent] |
0.19
(0.70)
|
-0.45
(0.81)
|
| Title | Change in HbA1c From Baseline to Week 66 |
|---|---|
| Description | |
| Time Frame | Baseline and week 66 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 949 | 399 |
| Mean (Standard Deviation) [percent] |
0.14
(0.73)
|
-0.44
(0.85)
|
| Title | Change in HbA1c From Baseline to Week 78 |
|---|---|
| Description | |
| Time Frame | Baseline and week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 904 | 373 |
| Mean (Standard Deviation) [percent] |
0.12
(0.76)
|
-0.49
(0.85)
|
| Title | Number of Patients With HbA1c<7.0% Over Time |
|---|---|
| Description | |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 904 | 373 |
| Number [participants] |
382
24.9%
|
172
29.2%
|
| Title | Number of Patients With HbA1c<6.5% Over Time |
|---|---|
| Description | |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 904 | 373 |
| Number [participants] |
139
9.1%
|
74
12.6%
|
| Title | Number of Patients With Lowered HbA1c by at Least 0.5% Over Time |
|---|---|
| Description | |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 904 | 373 |
| Number [participants] |
155
10.1%
|
175
29.7%
|
| Title | Change in FPG From Baseline to Week 6 |
|---|---|
| Description | |
| Time Frame | Baseline and week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1413 | 531 |
| Mean (Standard Deviation) [mg/dL] |
1.21
(30.54)
|
-15.17
(30.84)
|
| Title | Change in FPG From Baseline to Week 18 |
|---|---|
| Description | |
| Time Frame | Baseline and week 18 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1270 | 499 |
| Mean (Standard Deviation) [mg/dL] |
2.13
(31.47)
|
-13.92
(33.54)
|
| Title | Change in FPG From Baseline to Week 30 |
|---|---|
| Description | |
| Time Frame | Baseline and week 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1166 | 466 |
| Mean (Standard Deviation) [mg/dL] |
1.52
(31.84)
|
-16.17
(33.00)
|
| Title | Change in FPG From Baseline to Week 42 |
|---|---|
| Description | |
| Time Frame | Baseline and week 42 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1073 | 437 |
| Mean (Standard Deviation) [mg/dL] |
2.97
(31.07)
|
-11.87
(31.27)
|
| Title | Change in FPG From Baseline to Week 54 |
|---|---|
| Description | |
| Time Frame | Baseline and week 54 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1004 | 416 |
| Mean (Standard Deviation) [mg/dL] |
3.44
(30.52)
|
-12.62
(30.96)
|
| Title | Change in FPG From Baseline to Week 66 |
|---|---|
| Description | |
| Time Frame | Baseline and week 66 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 955 | 398 |
| Mean (Standard Deviation) [mg/dL] |
0.88
(31.96)
|
-12.87
(30.16)
|
| Title | Change in FPG From Baseline to Week 78 |
|---|---|
| Description | |
| Time Frame | Baseline and week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing. |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 904 | 366 |
| Mean (Standard Deviation) [mg/dL] |
1.90
(34.11)
|
-13.64
(31.67)
|
| Title | Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol |
|---|---|
| Description | For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL. |
| Time Frame | 78 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set with values for Cholesterol |
| Arm/Group Title | Old Lina | New Lina |
|---|---|---|
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo |
| Measure Participants | 1514 | 579 |
| Number [participants] |
1
0.1%
|
1
0.2%
|
Adverse Events
| Time Frame | 78 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Old Lina | New Lina | ||
| Arm/Group Description | Patients pre-treated with linagliptin | Patients pre-treated with placebo | ||
All Cause Mortality |
||||
| Old Lina | New Lina | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Old Lina | New Lina | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 158/1532 (10.3%) | 52/589 (8.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Hypochromic anaemia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/1532 (0%) | 4/589 (0.7%) | ||
| Angina pectoris | 4/1532 (0.3%) | 3/589 (0.5%) | ||
| Angina unstable | 4/1532 (0.3%) | 2/589 (0.3%) | ||
| Atrial fibrillation | 2/1532 (0.1%) | 2/589 (0.3%) | ||
| Atrial flutter | 2/1532 (0.1%) | 0/589 (0%) | ||
| Atrial tachycardia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Atrioventricular block second degree | 1/1532 (0.1%) | 0/589 (0%) | ||
| Bradycardia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cardiac failure | 3/1532 (0.2%) | 0/589 (0%) | ||
| Cardiac failure acute | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cardiac failure chronic | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Cardiac failure congestive | 0/1532 (0%) | 1/589 (0.2%) | ||
| Cardiac tamponade | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cardio-respiratory arrest | 0/1532 (0%) | 1/589 (0.2%) | ||
| Coronary artery disease | 3/1532 (0.2%) | 0/589 (0%) | ||
| Left ventricular failure | 1/1532 (0.1%) | 0/589 (0%) | ||
| Myocardial infarction | 2/1532 (0.1%) | 6/589 (1%) | ||
| Myocardial ischaemia | 2/1532 (0.1%) | 2/589 (0.3%) | ||
| Right ventricular failure | 0/1532 (0%) | 1/589 (0.2%) | ||
| Supraventricular tachycardia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Dolichocolon | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ear and labyrinth disorders | ||||
| Sudden hearing loss | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vertigo | 1/1532 (0.1%) | 0/589 (0%) | ||
| Endocrine disorders | ||||
| Goitre | 1/1532 (0.1%) | 0/589 (0%) | ||
| Eye disorders | ||||
| Cataract | 2/1532 (0.1%) | 0/589 (0%) | ||
| Diabetic retinopathy | 1/1532 (0.1%) | 0/589 (0%) | ||
| Macular hole | 1/1532 (0.1%) | 0/589 (0%) | ||
| Retinal degeneration | 0/1532 (0%) | 1/589 (0.2%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 1/1532 (0.1%) | 0/589 (0%) | ||
| Anal fistula | 1/1532 (0.1%) | 0/589 (0%) | ||
| Duodenal ulcer | 2/1532 (0.1%) | 0/589 (0%) | ||
| Gastric ulcer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Gastric ulcer perforation | 0/1532 (0%) | 1/589 (0.2%) | ||
| Inguinal hernia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Intestinal obstruction | 0/1532 (0%) | 1/589 (0.2%) | ||
| Oesophageal ulcer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Pancreatitis acute | 2/1532 (0.1%) | 0/589 (0%) | ||
| Pancreatitis chronic | 1/1532 (0.1%) | 0/589 (0%) | ||
| Peritoneal cyst | 0/1532 (0%) | 1/589 (0.2%) | ||
| Peritonitis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Volvulus | 1/1532 (0.1%) | 0/589 (0%) | ||
| Chest discomfort | 1/1532 (0.1%) | 0/589 (0%) | ||
| General disorders | ||||
| Chest pain | 5/1532 (0.3%) | 2/589 (0.3%) | ||
| Generalised oedema | 0/1532 (0%) | 1/589 (0.2%) | ||
| Local swelling | 0/1532 (0%) | 1/589 (0.2%) | ||
| Non-cardiac chest pain | 0/1532 (0%) | 2/589 (0.3%) | ||
| Polyp | 1/1532 (0.1%) | 0/589 (0%) | ||
| Sudden cardiac death | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ulcer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vaccination site hypersensitivity | 1/1532 (0.1%) | 0/589 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholangitis acute | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cholecystitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cholecystitis acute | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cholelithiasis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Hepatitis acute | 1/1532 (0.1%) | 0/589 (0%) | ||
| Immune system disorders | ||||
| Polyarteritis nodosa | 1/1532 (0.1%) | 0/589 (0%) | ||
| Infections and infestations | ||||
| Abscess limb | 0/1532 (0%) | 1/589 (0.2%) | ||
| Amoebic dysentery | 1/1532 (0.1%) | 0/589 (0%) | ||
| Anal abscess | 1/1532 (0.1%) | 0/589 (0%) | ||
| Appendicitis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Appendicitis perforated | 1/1532 (0.1%) | 0/589 (0%) | ||
| Bronchitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Campylobacter intestinal infection | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cellulitis | 4/1532 (0.3%) | 0/589 (0%) | ||
| Chikungunya virus infection | 0/1532 (0%) | 1/589 (0.2%) | ||
| Cystitis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Dengue fever | 1/1532 (0.1%) | 0/589 (0%) | ||
| Endocarditis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Gastroenteritis | 4/1532 (0.3%) | 0/589 (0%) | ||
| Gastrointestinal infection | 1/1532 (0.1%) | 0/589 (0%) | ||
| Herpes zoster | 0/1532 (0%) | 1/589 (0.2%) | ||
| Infected skin ulcer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Peritoneal infection | 0/1532 (0%) | 1/589 (0.2%) | ||
| Pneumonia | 3/1532 (0.2%) | 2/589 (0.3%) | ||
| Post procedural infection | 1/1532 (0.1%) | 0/589 (0%) | ||
| Postoperative wound infection | 1/1532 (0.1%) | 0/589 (0%) | ||
| Pyelonephritis acute | 0/1532 (0%) | 1/589 (0.2%) | ||
| Septic shock | 1/1532 (0.1%) | 0/589 (0%) | ||
| Upper respiratory tract infection | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vestibular neuronitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Viral infection | 0/1532 (0%) | 1/589 (0.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Accident | 0/1532 (0%) | 1/589 (0.2%) | ||
| Ankle fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Excoriation | 1/1532 (0.1%) | 0/589 (0%) | ||
| Fall | 0/1532 (0%) | 1/589 (0.2%) | ||
| Femur fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Fibula fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Foot fracture | 0/1532 (0%) | 2/589 (0.3%) | ||
| Hand fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Head injury | 2/1532 (0.1%) | 0/589 (0%) | ||
| Hip fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Humerus fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Joint dislocation | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ligament rupture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Lower limb fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Meniscus lesion | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Muscle strain | 0/1532 (0%) | 1/589 (0.2%) | ||
| Peripheral nerve injury | 1/1532 (0.1%) | 0/589 (0%) | ||
| Radius fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Rib fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Road traffic accident | 3/1532 (0.2%) | 2/589 (0.3%) | ||
| Scapula fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Skin injury | 0/1532 (0%) | 1/589 (0.2%) | ||
| Skin laceration | 2/1532 (0.1%) | 0/589 (0%) | ||
| Snake bite | 1/1532 (0.1%) | 0/589 (0%) | ||
| Spinal compression fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Tibia fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Traumatic brain injury | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ulna fracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vaccination complication | 1/1532 (0.1%) | 0/589 (0%) | ||
| Wound dehiscence | 0/1532 (0%) | 1/589 (0.2%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Hypoglycaemia | 2/1532 (0.1%) | 0/589 (0%) | ||
| Hyponatraemia | 0/1532 (0%) | 1/589 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Back pain | 3/1532 (0.2%) | 0/589 (0%) | ||
| Dupuytren's contracture | 1/1532 (0.1%) | 0/589 (0%) | ||
| Intervertebral disc disorder | 1/1532 (0.1%) | 0/589 (0%) | ||
| Intervertebral disc protrusion | 1/1532 (0.1%) | 0/589 (0%) | ||
| Lumbar spinal stenosis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Osteoarthritis | 3/1532 (0.2%) | 1/589 (0.2%) | ||
| Periarthritis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Rhabdomyolysis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Rotator cuff syndrome | 3/1532 (0.2%) | 0/589 (0%) | ||
| Spinal column stenosis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Spinal osteoarthritis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Spondylolisthesis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Synovitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Tenosynovitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bladder cancer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Bone sarcoma | 1/1532 (0.1%) | 0/589 (0%) | ||
| Breast cancer | 3/1532 (0.2%) | 1/589 (0.2%) | ||
| Colon cancer | 2/1532 (0.1%) | 0/589 (0%) | ||
| Colon neoplasm | 0/1532 (0%) | 1/589 (0.2%) | ||
| Endometrial cancer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Gastric cancer | 2/1532 (0.1%) | 0/589 (0%) | ||
| Lipoma | 1/1532 (0.1%) | 0/589 (0%) | ||
| Lung neoplasm malignant | 1/1532 (0.1%) | 0/589 (0%) | ||
| Metastases to liver | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Metastases to lymph nodes | 1/1532 (0.1%) | 0/589 (0%) | ||
| Osteoma | 1/1532 (0.1%) | 0/589 (0%) | ||
| Pancreatic neoplasm | 0/1532 (0%) | 1/589 (0.2%) | ||
| Prostate cancer | 7/1532 (0.5%) | 0/589 (0%) | ||
| Rectal cancer | 1/1532 (0.1%) | 0/589 (0%) | ||
| Renal cell carcinoma | 0/1532 (0%) | 1/589 (0.2%) | ||
| Thyroid cancer | 2/1532 (0.1%) | 0/589 (0%) | ||
| Tonsillar neoplasm | 1/1532 (0.1%) | 0/589 (0%) | ||
| Uterine leiomyoma | 1/1532 (0.1%) | 0/589 (0%) | ||
| Nervous system disorders | ||||
| Cerebral infarction | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cerebral ischaemia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cerebrovascular accident | 3/1532 (0.2%) | 1/589 (0.2%) | ||
| Cerebrovascular disorder | 1/1532 (0.1%) | 0/589 (0%) | ||
| Cervical myelopathy | 1/1532 (0.1%) | 0/589 (0%) | ||
| Dizziness | 1/1532 (0.1%) | 0/589 (0%) | ||
| Headache | 1/1532 (0.1%) | 0/589 (0%) | ||
| Intracranial aneurysm | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ischaemic stroke | 1/1532 (0.1%) | 0/589 (0%) | ||
| Nerve root compression | 1/1532 (0.1%) | 0/589 (0%) | ||
| Paraesthesia | 0/1532 (0%) | 1/589 (0.2%) | ||
| Presyncope | 1/1532 (0.1%) | 0/589 (0%) | ||
| Radiculopathy | 1/1532 (0.1%) | 0/589 (0%) | ||
| Psychiatric disorders | ||||
| Depression | 0/1532 (0%) | 1/589 (0.2%) | ||
| Renal and urinary disorders | ||||
| Calculus ureteric | 1/1532 (0.1%) | 0/589 (0%) | ||
| Haematuria | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Nephrolithiasis | 4/1532 (0.3%) | 0/589 (0%) | ||
| Renal failure acute | 2/1532 (0.1%) | 0/589 (0%) | ||
| Renal failure chronic | 1/1532 (0.1%) | 0/589 (0%) | ||
| Renal tubular necrosis | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 2/1532 (0.1%) | 1/589 (0.2%) | ||
| Cervical polyp | 1/1532 (0.1%) | 0/589 (0%) | ||
| Fallopian tube cyst | 1/1532 (0.1%) | 0/589 (0%) | ||
| Menorrhagia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Metrorrhagia | 1/1532 (0.1%) | 0/589 (0%) | ||
| Ovarian cyst | 1/1532 (0.1%) | 0/589 (0%) | ||
| Uterine haemorrhage | 1/1532 (0.1%) | 0/589 (0%) | ||
| Uterine polyp | 1/1532 (0.1%) | 0/589 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/1532 (0.1%) | 0/589 (0%) | ||
| Epistaxis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Hiccups | 1/1532 (0.1%) | 0/589 (0%) | ||
| Pulmonary embolism | 2/1532 (0.1%) | 0/589 (0%) | ||
| Pulmonary hypertension | 1/1532 (0.1%) | 0/589 (0%) | ||
| Respiratory failure | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vocal cord polyp | 1/1532 (0.1%) | 0/589 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 1/1532 (0.1%) | 0/589 (0%) | ||
| Dermatitis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Urticaria | 1/1532 (0.1%) | 0/589 (0%) | ||
| Surgical and medical procedures | ||||
| Intra-uterine contraceptive device removal | 1/1532 (0.1%) | 0/589 (0%) | ||
| Vascular disorders | ||||
| Aortic stenosis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Arteriosclerosis | 0/1532 (0%) | 1/589 (0.2%) | ||
| Hypertension | 2/1532 (0.1%) | 0/589 (0%) | ||
| Hypertensive crisis | 1/1532 (0.1%) | 0/589 (0%) | ||
| Hypertensive emergency | 1/1532 (0.1%) | 0/589 (0%) | ||
| Peripheral arterial occlusive disease | 1/1532 (0.1%) | 1/589 (0.2%) | ||
| Peripheral artery aneurysm | 0/1532 (0%) | 1/589 (0.2%) | ||
| Varicose vein | 1/1532 (0.1%) | 0/589 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Old Lina | New Lina | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 784/1532 (51.2%) | 285/589 (48.4%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 164/1532 (10.7%) | 62/589 (10.5%) | ||
| Upper respiratory tract infection | 122/1532 (8%) | 54/589 (9.2%) | ||
| Urinary tract infection | 74/1532 (4.8%) | 33/589 (5.6%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | 376/1532 (24.5%) | 121/589 (20.5%) | ||
| Hypoglycaemia | 200/1532 (13.1%) | 85/589 (14.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 69/1532 (4.5%) | 31/589 (5.3%) | ||
| Vascular disorders | ||||
| Hypertension | 67/1532 (4.4%) | 30/589 (5.1%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00736099
Other Study ID Numbers:
- 1218.40
- 2008-000750-13
First Posted:
Aug 15, 2008
Last Update Posted:
Jun 27, 2014
Last Verified:
Dec 1, 2013