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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/NCT01084005
Registration number
NCT01084005
Ethics application status
Date submitted
9/03/2010
Date registered
10/03/2010
Date last updated
29/01/2014
Titles & IDs
Public title
Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
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Scientific title
A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy
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Secondary ID [1]
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2009-015255-25
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Secondary ID [2]
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1218.63
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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 - placebo
Experimental: linagliptin - patients receive linagliptin 5 mg tablets once daily
Placebo Comparator: placebo - patients receive placebo tablets matching linagliptin 5 mg once daily
Treatment: Drugs: linagliptin
patients receive linagliptin 5 mg tablets once daily
Treatment: Drugs: placebo
patients receive placebo matching linagliptin 5 mg 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 to 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 prior use of insulin.
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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 to 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 prior use of insulin.
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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 to 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 prior use of insulin.
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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 to 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 prior use of insulin.
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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 to 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 prior use of insulin.
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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 to 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 prior use of insulin, week repeated within patient and week by treatment interaction.
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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 to 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 prior use of insulin, week repeated within patient and week by treatment interaction.
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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 to 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 prior use of insulin, week repeated within patient and week by treatment interaction.
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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% 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 above 7%. 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% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
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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 Who Have a HbA1c Lowering by at Least 0.5% at Week 24
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Assessment method [10]
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The percentage of patients with an HbA1c reduction of =0.5% at week 24 from baseline 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 [10]
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Baseline and week 24
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Secondary outcome [11]
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Number of Patients With Rescue Therapy
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Assessment method [11]
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The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial
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Timepoint [11]
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week 24
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Type 2 diabetes mellitus
2. HbA1c >= 7.0%
3. Age >= 70 years
4. Signed and dated written informed consent
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Minimum age
70
Years
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Maximum age
No limit
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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 TIA within 3 months prior to informed consent
2. Impaired hepatic function
3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or
pre-mixed insulins
4. Treatment with anti-obesity drugs
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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
1/03/2010
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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
241
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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1218.63.61005 Boehringer Ingelheim Investigational Site - Gosford
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Recruitment hospital [2]
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1218.63.61006 Boehringer Ingelheim Investigational Site - Herston
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Recruitment hospital [3]
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1218.63.61003 Boehringer Ingelheim Investigational Site - Adelaide
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Recruitment hospital [4]
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1218.63.61002 Boehringer Ingelheim Investigational Site - Daw Park
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Recruitment hospital [5]
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1218.63.61007 Boehringer Ingelheim Investigational Site - East Ringwood
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Recruitment hospital [6]
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1218.63.61001 Boehringer Ingelheim Investigational Site - Parkville
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Recruitment hospital [7]
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1218.63.61004 Boehringer Ingelheim Investigational Site - Reservoir
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Recruitment postcode(s) [1]
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- Gosford
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Daw Park
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Recruitment postcode(s) [5]
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- East Ringwood
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Reservoir
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Canada
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State/province [3]
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Quebec
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Country [4]
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Canada
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State/province [4]
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Saskatchewan
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Country [5]
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Denmark
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State/province [5]
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Aalborg
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Country [6]
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Denmark
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State/province [6]
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Aarhus C
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Country [7]
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Denmark
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State/province [7]
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Birkerød
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Country [8]
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Denmark
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State/province [8]
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Hellerup
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Country [9]
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Denmark
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State/province [9]
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Hillerød
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Country [10]
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Denmark
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State/province [10]
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Hvidovre
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Country [11]
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Denmark
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State/province [11]
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København NV
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Country [12]
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Netherlands
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State/province [12]
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Beek en Donk
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Country [13]
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Netherlands
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State/province [13]
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Beerzerveld
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Country [14]
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Netherlands
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State/province [14]
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Doetinchem
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Country [15]
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Netherlands
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State/province [15]
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Etten-Leur
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Country [16]
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Netherlands
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State/province [16]
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Oude Pekela
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Country [17]
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Netherlands
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State/province [17]
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Tubbergen
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Country [18]
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Sweden
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State/province [18]
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Göteborg
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Country [19]
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Sweden
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State/province [19]
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Järfälla
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Country [20]
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Sweden
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State/province [20]
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Malmö
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Country [21]
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Sweden
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State/province [21]
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Sundsvall
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Country [22]
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Sweden
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State/province [22]
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Eli Lilly and Company
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Address [1]
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Country [1]
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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
linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to
stable treatment in elderly patients with T2DM with insufficient glycaemic control
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01084005
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01084005
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