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Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00736099
Registration number
NCT00736099
Ethics application status
Date submitted
14/08/2008
Date registered
15/08/2008
Date last updated
27/06/2014
Titles & IDs
Public title
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
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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.
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Secondary ID [1]
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0
2008-000750-13
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Secondary ID [2]
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0
1218.40
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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0
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Condition category
Condition code
Metabolic and Endocrine
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0
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency of Patients With Adverse Events (AEs)
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Assessment method [1]
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This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
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Timepoint [1]
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78 weeks
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Primary outcome [2]
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Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events
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Assessment method [2]
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0
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Timepoint [2]
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78 weeks
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Primary outcome [3]
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Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)
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Assessment method [3]
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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'').
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Timepoint [3]
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0
78 weeks
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Primary outcome [4]
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Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events
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Assessment method [4]
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Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)
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Timepoint [4]
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78 weeks
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Primary outcome [5]
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Number of Patients With Abnormalities in Vital Signs
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Assessment method [5]
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Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)
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Timepoint [5]
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0
78 weeks
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Primary outcome [6]
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Number of Patients With Abnormalities in Haematology: Eosinophils
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Assessment method [6]
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For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.
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Timepoint [6]
0
0
78 weeks
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Primary outcome [7]
0
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Number of Patients With Abnormalities in Haematology: Haemoglobin
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Assessment method [7]
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0
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.
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Timepoint [7]
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0
78 weeks
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Primary outcome [8]
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Number of Patients With Abnormalities in Haematology: Haematocrit
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Assessment method [8]
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0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.
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Timepoint [8]
0
0
78 weeks
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Primary outcome [9]
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Number of Patients With Abnormalities in Haematology: Red Blood Cell Count
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Assessment method [9]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 \* 10\^12/L.
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Timepoint [9]
0
0
78 weeks
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Primary outcome [10]
0
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Number of Patients With Abnormalities in Haematology: White Blood Cell Count
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Assessment method [10]
0
0
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).
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Timepoint [10]
0
0
78 weeks
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Primary outcome [11]
0
0
Number of Patients With Abnormalities in Haematology: Platelets
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Assessment method [11]
0
0
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).
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Timepoint [11]
0
0
78 weeks
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Primary outcome [12]
0
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Number of Patients With Abnormalities in Clinical Chemistry: Potassium
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Assessment method [12]
0
0
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).
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Timepoint [12]
0
0
78 weeks
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Primary outcome [13]
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Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid
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Assessment method [13]
0
0
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.
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Timepoint [13]
0
0
78 weeks
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Primary outcome [14]
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Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides
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Assessment method [14]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
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Timepoint [14]
0
0
78 weeks
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Primary outcome [15]
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Number of Patients With Abnormalities in Clinical Chemistry: Amylase
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Assessment method [15]
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0
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).
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Timepoint [15]
0
0
78 weeks
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Primary outcome [16]
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Number of Patients With Abnormalities in Clinical Chemistry: ?-Glutamyl-transferase (GGT)
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Assessment method [16]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
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Timepoint [16]
0
0
78 weeks
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Primary outcome [17]
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Number of Patients With Abnormalities in Clinical Chemistry: Creatinine
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Assessment method [17]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.
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Timepoint [17]
0
0
78 weeks
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Primary outcome [18]
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0
Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase
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Assessment method [18]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
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Timepoint [18]
0
0
78 weeks
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Primary outcome [19]
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Number of Patients With Abnormalities in Clinical Chemistry: Phosphate
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Assessment method [19]
0
0
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).
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Timepoint [19]
0
0
78 weeks
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Primary outcome [20]
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Number of Patients With Abnormalities in Clinical Chemistry: Calcium
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Assessment method [20]
0
0
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).
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Timepoint [20]
0
0
78 weeks
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Primary outcome [21]
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Number of Patients With Abnormalities in Clinical Chemistry: Sodium
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Assessment method [21]
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0
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).
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Timepoint [21]
0
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78 weeks
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Primary outcome [22]
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Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)
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Assessment method [22]
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For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
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Timepoint [22]
0
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78 weeks
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Primary outcome [23]
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Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)
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Assessment method [23]
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0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
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Timepoint [23]
0
0
78 weeks
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Primary outcome [24]
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Number of Patients With Abnormalities in Clinical Chemistry: Glucose
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Assessment method [24]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.
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Timepoint [24]
0
0
78 weeks
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Primary outcome [25]
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Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin
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Assessment method [25]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.
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Timepoint [25]
0
0
78 weeks
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Primary outcome [26]
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0
Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)
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Assessment method [26]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.
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Timepoint [26]
0
0
78 weeks
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Primary outcome [27]
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Number of Patients With Abnormalities in Clinical Chemistry: Albumin
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Assessment method [27]
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0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.
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Timepoint [27]
0
0
78 weeks
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Primary outcome [28]
0
0
Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)
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Assessment method [28]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.
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Timepoint [28]
0
0
78 weeks
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Primary outcome [29]
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0
Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol
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Assessment method [29]
0
0
For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.
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Timepoint [29]
0
0
78 weeks
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Secondary outcome [1]
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0
Change in HbA1c From Baseline to Week 6
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Assessment method [1]
0
0
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Timepoint [1]
0
0
Baseline and week 6
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Secondary outcome [2]
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0
Change in HbA1c From Baseline to Week 18
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Assessment method [2]
0
0
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Timepoint [2]
0
0
Baseline and week 18
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Secondary outcome [3]
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0
Change in HbA1c From Baseline to Week 30
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Baseline and week 30
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Secondary outcome [4]
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0
Change in HbA1c From Baseline to Week 42
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Assessment method [4]
0
0
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Timepoint [4]
0
0
Baseline and week 42
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Secondary outcome [5]
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0
Change in HbA1c From Baseline to Week 54
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Assessment method [5]
0
0
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Timepoint [5]
0
0
Baseline and week 54
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Secondary outcome [6]
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0
Change in HbA1c From Baseline to Week 66
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Assessment method [6]
0
0
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Timepoint [6]
0
0
Baseline and week 66
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Secondary outcome [7]
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0
Change in HbA1c From Baseline to Week 78
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Assessment method [7]
0
0
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Timepoint [7]
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0
Baseline and week 78
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Secondary outcome [8]
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Number of Patients With HbA1c<7.0% Over Time
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Assessment method [8]
0
0
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Timepoint [8]
0
0
78 weeks
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Secondary outcome [9]
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0
Number of Patients With HbA1c<6.5% Over Time
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Assessment method [9]
0
0
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Timepoint [9]
0
0
78 weeks
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Secondary outcome [10]
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0
Number of Patients With Lowered HbA1c by at Least 0.5% Over Time
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Assessment method [10]
0
0
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Timepoint [10]
0
0
78 weeks
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Secondary outcome [11]
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0
Change in FPG From Baseline to Week 6
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Assessment method [11]
0
0
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Timepoint [11]
0
0
Baseline and week 6
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Secondary outcome [12]
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0
Change in FPG From Baseline to Week 18
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Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Baseline and week 18
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Secondary outcome [13]
0
0
Change in FPG From Baseline to Week 30
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Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Baseline and week 30
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Secondary outcome [14]
0
0
Change in FPG From Baseline to Week 42
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Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Baseline and week 42
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Secondary outcome [15]
0
0
Change in FPG From Baseline to Week 54
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Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Baseline and week 54
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Secondary outcome [16]
0
0
Change in FPG From Baseline to Week 66
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Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Baseline and week 66
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Secondary outcome [17]
0
0
Change in FPG From Baseline to Week 78
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Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Baseline and week 78
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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.
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Minimum age
18
Years
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Maximum age
82
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
2122
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Oregon
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Country [5]
0
0
United States of America
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State/province [5]
0
0
South Carolina
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Texas
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Washington
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Capital Federal
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Mendoza
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Parque Velez Sarfield
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Country [11]
0
0
Austria
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State/province [11]
0
0
Graz
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Country [12]
0
0
Austria
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State/province [12]
0
0
Wien
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Country [13]
0
0
Belgium
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State/province [13]
0
0
Brugge
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Country [14]
0
0
Belgium
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State/province [14]
0
0
Brussel
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Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Edegem
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Genk
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Gent
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Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Huy
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Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Liège
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Alberta
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Country [21]
0
0
Canada
Query!
State/province [21]
0
0
British Columbia
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Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Ontario
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Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Prince Edward Island
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Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Saskatchewan
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Beijing
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Chengdu
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Dalian
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Guangzhou
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Haerbin
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Qingdao
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Shenyang
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Wuhan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Xi'An
Query!
Country [35]
0
0
Croatia
Query!
State/province [35]
0
0
Krapinske Toplice
Query!
Country [36]
0
0
Croatia
Query!
State/province [36]
0
0
Slavonski Brod
Query!
Country [37]
0
0
Czech Republic
Query!
State/province [37]
0
0
Breclav
Query!
Country [38]
0
0
Czech Republic
Query!
State/province [38]
0
0
Brno
Query!
Country [39]
0
0
Czech Republic
Query!
State/province [39]
0
0
Hodonin
Query!
Country [40]
0
0
Czech Republic
Query!
State/province [40]
0
0
Olomouc
Query!
Country [41]
0
0
Finland
Query!
State/province [41]
0
0
Helsinki
Query!
Country [42]
0
0
Finland
Query!
State/province [42]
0
0
Kuopio
Query!
Country [43]
0
0
Finland
Query!
State/province [43]
0
0
Oulu
Query!
Country [44]
0
0
Finland
Query!
State/province [44]
0
0
Seinäjoki
Query!
Country [45]
0
0
Finland
Query!
State/province [45]
0
0
Turku
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Bad Mergentheim
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Berlin
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Bosenheim
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Dresden
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Mainz
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Neuwied
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Nürnberg
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Saarbrücken
Query!
Country [54]
0
0
Greece
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Japan
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Koganei, Tokyo
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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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Busan
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Seoul
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Suwon
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Perak
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Mexico
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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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Deurne
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Ewijk
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Netherlands
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Losser
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Netherlands
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Netherlands
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Wildervank
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Christchurch
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Otahuhu
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Tauranga
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Wellington
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Pasig
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Russian Federation
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Russian Federation
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Perm
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Spain
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Madrid
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Ukraine
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Ukraine
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United Kingdom
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Ashford
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United Kingdom
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Baillieston, Glasgow
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United Kingdom
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Bath
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Burbage
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United Kingdom
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United Kingdom
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Reading
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United Kingdom
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Waterloo, Liverpool
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Funding & Sponsors
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Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
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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)
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Trial website
https://clinicaltrials.gov/study/NCT00736099
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00736099
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