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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00736099




Registration number
NCT00736099
Ethics application status
Date submitted
14/08/2008
Date registered
14/08/2008
Date last updated
18/06/2014

Titles & IDs
Public title
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Scientific 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.
Secondary ID [1] 0 0
2008-000750-13
Secondary ID [2] 0 0
1218.40
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - linagliptine 5 mg
Treatment: Drugs - linagliptine 5 mg and pioglitazone 30 mg

Experimental: linagliptin 5 mg - open label

Experimental: linagliptin 5 mg and pioglitazone 30 mg - open label


Treatment: Drugs: linagliptine 5 mg
safety and efficacy of linagliptine 5 mg open label

Treatment: Drugs: linagliptine 5 mg and pioglitazone 30 mg
efficacy and safety of the combination linagliptine and pioglitazone

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Patients With Adverse Events (AEs) - This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Timepoint [1] 0 0
78 weeks
Primary outcome [2] 0 0
Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
Timepoint [2] 0 0
78 weeks
Primary outcome [3] 0 0
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'').
Timepoint [3] 0 0
78 weeks
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
78 weeks
Primary outcome [5] 0 0
Number of Patients With Abnormalities in Vital Signs - Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
Timepoint [5] 0 0
78 weeks
Primary outcome [6] 0 0
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%.
Timepoint [6] 0 0
78 weeks
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
78 weeks
Primary outcome [8] 0 0
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%.
Timepoint [8] 0 0
78 weeks
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
78 weeks
Primary outcome [10] 0 0
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).
Timepoint [10] 0 0
78 weeks
Primary outcome [11] 0 0
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).
Timepoint [11] 0 0
78 weeks
Primary outcome [12] 0 0
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).
Timepoint [12] 0 0
78 weeks
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
78 weeks
Primary outcome [14] 0 0
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.
Timepoint [14] 0 0
78 weeks
Primary outcome [15] 0 0
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).
Timepoint [15] 0 0
78 weeks
Primary outcome [16] 0 0
Number of Patients With Abnormalities in Clinical Chemistry: ?-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.
Timepoint [16] 0 0
78 weeks
Primary outcome [17] 0 0
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.
Timepoint [17] 0 0
78 weeks
Primary outcome [18] 0 0
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.
Timepoint [18] 0 0
78 weeks
Primary outcome [19] 0 0
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).
Timepoint [19] 0 0
78 weeks
Primary outcome [20] 0 0
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).
Timepoint [20] 0 0
78 weeks
Primary outcome [21] 0 0
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).
Timepoint [21] 0 0
78 weeks
Primary outcome [22] 0 0
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.
Timepoint [22] 0 0
78 weeks
Primary outcome [23] 0 0
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.
Timepoint [23] 0 0
78 weeks
Primary outcome [24] 0 0
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.
Timepoint [24] 0 0
78 weeks
Primary outcome [25] 0 0
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.
Timepoint [25] 0 0
78 weeks
Primary outcome [26] 0 0
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.
Timepoint [26] 0 0
78 weeks
Primary outcome [27] 0 0
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.
Timepoint [27] 0 0
78 weeks
Primary outcome [28] 0 0
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.
Timepoint [28] 0 0
78 weeks
Primary outcome [29] 0 0
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.
Timepoint [29] 0 0
78 weeks
Secondary outcome [1] 0 0
Change in HbA1c From Baseline to Week 6
Timepoint [1] 0 0
Baseline and week 6
Secondary outcome [2] 0 0
Change in HbA1c From Baseline to Week 18
Timepoint [2] 0 0
Baseline and week 18
Secondary outcome [3] 0 0
Change in HbA1c From Baseline to Week 30
Timepoint [3] 0 0
Baseline and week 30
Secondary outcome [4] 0 0
Change in HbA1c From Baseline to Week 42
Timepoint [4] 0 0
Baseline and week 42
Secondary outcome [5] 0 0
Change in HbA1c From Baseline to Week 54
Timepoint [5] 0 0
Baseline and week 54
Secondary outcome [6] 0 0
Change in HbA1c From Baseline to Week 66
Timepoint [6] 0 0
Baseline and week 66
Secondary outcome [7] 0 0
Change in HbA1c From Baseline to Week 78
Timepoint [7] 0 0
Baseline and week 78
Secondary outcome [8] 0 0
Number of Patients With HbA1c<7.0% Over Time
Timepoint [8] 0 0
78 weeks
Secondary outcome [9] 0 0
Number of Patients With HbA1c<6.5% Over Time
Timepoint [9] 0 0
78 weeks
Secondary outcome [10] 0 0
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
Timepoint [10] 0 0
78 weeks
Secondary outcome [11] 0 0
Change in FPG From Baseline to Week 6
Timepoint [11] 0 0
Baseline and week 6
Secondary outcome [12] 0 0
Change in FPG From Baseline to Week 18
Timepoint [12] 0 0
Baseline and week 18
Secondary outcome [13] 0 0
Change in FPG From Baseline to Week 30
Timepoint [13] 0 0
Baseline and week 30
Secondary outcome [14] 0 0
Change in FPG From Baseline to Week 42
Timepoint [14] 0 0
Baseline and week 42
Secondary outcome [15] 0 0
Change in FPG From Baseline to Week 54
Timepoint [15] 0 0
Baseline and week 54
Secondary outcome [16] 0 0
Change in FPG From Baseline to Week 66
Timepoint [16] 0 0
Baseline and week 66
Secondary outcome [17] 0 0
Change in FPG From Baseline to Week 78
Timepoint [17] 0 0
Baseline and week 78

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed and dated written informed consent in accordance with the GCP and local
legislation.

2. Patients completing the entire treatment period as a double blind trial whether or not
they have been treated with rescue medication.
Minimum age
18 Years
Maximum age
82 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Patients who meet one or more of the withdrawal criteria of the treatment period of
the previous trial.

2. 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.

3. Alcohol abuse within the 3 months prior to informed consent that would interfere with
trial participation.

4. Drug abuse which, in the opinion of the investigator, would interfere with trial
participation.

5. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Capital Federal
Country [9] 0 0
Argentina
State/province [9] 0 0
Mendoza
Country [10] 0 0
Argentina
State/province [10] 0 0
Parque Velez Sarfield
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussel
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Genk
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Huy
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Prince Edward Island
Country [24] 0 0
Canada
State/province [24] 0 0
Saskatchewan
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Chengdu
Country [27] 0 0
China
State/province [27] 0 0
Dalian
Country [28] 0 0
China
State/province [28] 0 0
Guangzhou
Country [29] 0 0
China
State/province [29] 0 0
Haerbin
Country [30] 0 0
China
State/province [30] 0 0
Qingdao
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Shenyang
Country [33] 0 0
China
State/province [33] 0 0
Wuhan
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China
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Xi'An
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Croatia
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Krapinske Toplice
Country [36] 0 0
Croatia
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Slavonski Brod
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Breclav
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Czech Republic
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Brno
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Czech Republic
State/province [39] 0 0
Hodonin
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Olomouc
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Finland
State/province [42] 0 0
Kuopio
Country [43] 0 0
Finland
State/province [43] 0 0
Oulu
Country [44] 0 0
Finland
State/province [44] 0 0
Seinäjoki
Country [45] 0 0
Finland
State/province [45] 0 0
Turku
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Mergentheim
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Bosenheim
Country [49] 0 0
Germany
State/province [49] 0 0
Dresden
Country [50] 0 0
Germany
State/province [50] 0 0
Mainz
Country [51] 0 0
Germany
State/province [51] 0 0
Neuwied
Country [52] 0 0
Germany
State/province [52] 0 0
Nürnberg
Country [53] 0 0
Germany
State/province [53] 0 0
Saarbrücken
Country [54] 0 0
Greece
State/province [54] 0 0
Athens
Country [55] 0 0
Greece
State/province [55] 0 0
Nikaia
Country [56] 0 0
Greece
State/province [56] 0 0
Piraeus
Country [57] 0 0
Greece
State/province [57] 0 0
Thessaloniki
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Hungary
State/province [59] 0 0
Debrecen
Country [60] 0 0
Hungary
State/province [60] 0 0
Györ
Country [61] 0 0
Hungary
State/province [61] 0 0
Szombathely
Country [62] 0 0
India
State/province [62] 0 0
Andhra Pradesh
Country [63] 0 0
India
State/province [63] 0 0
Bangalore
Country [64] 0 0
India
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Chennai
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India
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Hyderabad, Andra Pradesh
Country [66] 0 0
India
State/province [66] 0 0
Jaipur
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India
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Kerala
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India
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Maharashtra
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India
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Mangalore
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India
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Manipal
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India
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Mumbai
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India
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Nasik
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India
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Uttar Pradesh
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Israel
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Afula
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
Country [78] 0 0
Israel
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Nahariya
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Israel
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Safed
Country [80] 0 0
Israel
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Tel Aviv
Country [81] 0 0
Italy
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Genova
Country [82] 0 0
Italy
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Milano
Country [83] 0 0
Italy
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Pisa
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Italy
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Roma
Country [85] 0 0
Japan
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Amagasaki, Hyogo
Country [86] 0 0
Japan
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Koganei, Tokyo
Country [87] 0 0
Japan
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Osaka, Osaka
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Japan
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Shinjyuku-ku,Tokyo
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Japan
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Suita, Osaka,
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Pusan
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Malaysia
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Kelantan
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Malaysia
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Kuala Lumpur
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Malaysia
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Penang
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Malaysia
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Perak
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Mexico
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Aguascalientes, Ags.
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Mexico
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Col.Americana, Guadalajara, Jalisco
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Mexico
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Colonia Tlalpan, mexico
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Mexico
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Faccionamiento Lomas de Campestre,AGUASCAL
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Mexico
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León
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Mexico
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Monterrey N.L.
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Mexico
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Monterrey
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Mexico
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México
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Netherlands
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Deurne
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Netherlands
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Ewijk
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Netherlands
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Losser
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Netherlands
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Roelofarendsveen
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Netherlands
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Wildervank
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Otahuhu
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New Zealand
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Tauranga
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New Zealand
State/province [118] 0 0
Wellington
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Philippines
State/province [119] 0 0
Greenhills, San Juan
Country [120] 0 0
Philippines
State/province [120] 0 0
Manila
Country [121] 0 0
Philippines
State/province [121] 0 0
Marikina
Country [122] 0 0
Philippines
State/province [122] 0 0
Pasig
Country [123] 0 0
Philippines
State/province [123] 0 0
Quezon City
Country [124] 0 0
Poland
State/province [124] 0 0
Lublin
Country [125] 0 0
Poland
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Warsaw
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Poland
State/province [126] 0 0
Zabrze
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Romania
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Alba Iulia
Country [128] 0 0
Romania
State/province [128] 0 0
Brasov
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Romania
State/province [129] 0 0
Bucharest
Country [130] 0 0
Romania
State/province [130] 0 0
Galati
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Romania
State/province [131] 0 0
Sibiu
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Romania
State/province [132] 0 0
Targu-Mures
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Russian Federation
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Arkhangelsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
Country [136] 0 0
Russian Federation
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Perm
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Rostov-on-Don
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Samara
Country [139] 0 0
Russian Federation
State/province [139] 0 0
St. Petersburg
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Tomsk
Country [141] 0 0
Slovakia
State/province [141] 0 0
Banska Bystrica
Country [142] 0 0
Slovakia
State/province [142] 0 0
Bratislava
Country [143] 0 0
Slovakia
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Nove Mesto
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Slovakia
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Samorin
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Spain
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Badalona
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Spain
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Badia del Vallés
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Spain
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Borges del Camp
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Spain
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Centelles
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Spain
State/province [149] 0 0
Granada
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Spain
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L'Hospitalet de Llobregat (Barcelona)
Country [151] 0 0
Spain
State/province [151] 0 0
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Sweden
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Uppsala
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ChangHua
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Taichung
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Kharkov
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Zaporizhzhya
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United Kingdom
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Ashford
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Waterloo, Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT00736099
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications