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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00601250
Registration number
NCT00601250
Ethics application status
Date submitted
15/01/2008
Date registered
28/01/2008
Date last updated
28/01/2014
Titles & IDs
Public title
Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes
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Scientific title
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
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Secondary ID [1]
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2007-002457-24
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Secondary ID [2]
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1218.17
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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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Condition category
Condition code
Metabolic and Endocrine
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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 - linagliptin
Treatment: Drugs - linagliptin
Experimental: Linagliptin - Patients receive linagliptin 5 mg tablets once daily
Placebo Comparator: Placebo - Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
Treatment: Drugs: linagliptin
Patients receive linagliptin 5 mg tablets once daily
Treatment: Drugs: linagliptin
Patients receive linagliptin 5 mg tablets once daily
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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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HbA1c Change From Baseline at Week 24
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Assessment method [1]
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HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
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Timepoint [1]
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Baseline and week 24
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Secondary outcome [1]
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HbA1c Change From Baseline at Week 6
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Assessment method [1]
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HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
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Timepoint [1]
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Baseline and week 6
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Secondary outcome [2]
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HbA1c Change From Baseline at Week 12
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Assessment method [2]
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HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
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Timepoint [2]
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Baseline and week 12
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Secondary outcome [3]
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HbA1c Change From Baseline at Week 18
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Assessment method [3]
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HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
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Timepoint [3]
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Baseline and week 18
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Secondary outcome [4]
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FPG Change From Baseline at Week 24
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Assessment method [4]
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This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
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Timepoint [4]
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Baseline and week 24
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Secondary outcome [5]
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FPG Change From Baseline at Week 6
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Assessment method [5]
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This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
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Timepoint [5]
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Baseline and week 6
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Secondary outcome [6]
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FPG Change From Baseline at Week 12
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Assessment method [6]
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This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
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Timepoint [6]
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Baseline and week 12
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Secondary outcome [7]
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FPG Change From Baseline at Week 18
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Assessment method [7]
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This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
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Timepoint [7]
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Baseline and week 18
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Secondary outcome [8]
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Percentage of Patients With HbA1c <7.0% at Week 24.
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Assessment method [8]
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The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%
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Timepoint [8]
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Baseline and week 24
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Secondary outcome [9]
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Percentage of Patients With HbA1c < 7.0% at Week 24
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Assessment method [9]
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The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.
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Timepoint [9]
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Baseline and week 24
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Secondary outcome [10]
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Percentage of Patients With HbA1c <6.5% at Week 24
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Assessment method [10]
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The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%
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Timepoint [10]
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Baseline and week 24
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Secondary outcome [11]
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Percentage of Patients With HbA1c<6.5% at Week 24
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Assessment method [11]
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The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.
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Timepoint [11]
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Baseline and week 24
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Secondary outcome [12]
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Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24
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Assessment method [12]
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The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.
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Timepoint [12]
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Baseline and week 24
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Secondary outcome [13]
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Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24
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Assessment method [13]
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This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.
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Timepoint [13]
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Baseline and week 24
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Secondary outcome [14]
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2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24
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Assessment method [14]
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This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.
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Timepoint [14]
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Baseline and week 24
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously
treated with metformin alone, or with metformin and not more than one other oral
antidiabetic drug
2. Diagnosis of type 2 diabetes prior to informed consent
3. Glycosylated haemoglobin A1 (HbA1c)at screening:
For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients
not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
5. Age 18 -80 years
6. BMI (Body Mass Index) less than 40 kg/m2
7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP
and local legislation
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Minimum age
18
Years
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Maximum age
80
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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. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior
to informed consent
2. Impaired hepatic function
3. Known hypersensitivity or allergy to the investigational product or its excipients or
metformin or placebo
4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to
informed consent
6. Treatment with insulin within 3 months prior to informed consent
7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3
months prior to informed consent
8. Alcohol abuse within the 3 months prior to informed consent that would interfere with
trial participation or drug abuse
9. Participation in another trial with an investigational drug within 2 months prior to
informed consent
10. Pre-menopausal women 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.
11. Current treatment with systemic steroids at time of informed consent or change in
dosage of thyroid hormones within 6 weeks prior to informed consent.
12. Renal failure or renal impairment
13. Unstable or acute congestive heart failure
14. Acute or chronic metabolic acidosis (present in patient history)
15. Hereditary galactose intolerance
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking 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
1/01/2008
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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
701
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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Nebraska
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North Carolina
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Ohio
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Breclav
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Brno
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Hodonin
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Jyväskylä
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Kuopio
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Finland
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Oulu
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Finland
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Seinäjoki
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Finland
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Turku
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Athens
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Haifa
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Holon
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Jerusalem
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Safed
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Tel Aviv
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Mexico
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Aguascalientes, Ags.
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cOL OBREGON,León, Guanajuato
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Tauranga
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Wellington
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Moscow
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Novosibirsk
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Perm
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Tomsk
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Härnösand
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Malmö
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Uddevalla
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of the current study is to investigate the efficacy, safety and tolerability of
BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to
metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00601250
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00601250
Download to PDF