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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01087502
Registration number
NCT01087502
Ethics application status
Date submitted
15/03/2010
Date registered
16/03/2010
Date last updated
27/06/2014
Titles & IDs
Public title
Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment
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Scientific title
A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
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Secondary ID [1]
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2009-016971-31
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Secondary ID [2]
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1218.64
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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 - Glimepiride
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Linagliptin
Experimental: Linagliptin - 52 weeks treatment
Placebo comparator: Placebo - First 12 weeks of treatment
Active comparator: Glimepiride - Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Treatment: Drugs: Glimepiride
1-4 mg daily after 12 weeks
Treatment: Drugs: Placebo
Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
Treatment: Drugs: Placebo
Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
Treatment: Drugs: Placebo
Placebo mach to 5 mg linagliptin once daily after 12 weeks
Treatment: Drugs: 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 12
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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 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
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Timepoint [1]
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Baseline and week 12
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Secondary outcome [1]
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HbA1c Change From Baseline Over Time
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Assessment method [1]
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HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
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Timepoint [1]
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Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52
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Secondary outcome [2]
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Fasting Plasma Glucose (FPG) Change From Baseline to Week 12
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Assessment method [2]
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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 [2]
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Baseline and week 12
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Secondary outcome [3]
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Fasting Plasma Glucose (FPG) Change From Baseline Over Time
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Assessment method [3]
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This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
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Timepoint [3]
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Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52
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Secondary outcome [4]
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Percentage of Patients With HbA1c <7.0%
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Assessment method [4]
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The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
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Timepoint [4]
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Baseline, week 12 and week 52
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Secondary outcome [5]
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Percentage of Patients With HbA1c <6.5%
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Assessment method [5]
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The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
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Timepoint [5]
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Baseline, week 12 and week 52
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Secondary outcome [6]
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Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%
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Assessment method [6]
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The percentage of patients with an HbA1c reduction of =0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
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Timepoint [6]
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Baseline, week 12 and week 52
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Secondary outcome [7]
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Plasma Concentration of Linagliptin at Trough
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Assessment method [7]
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Trough levels of concentration of Linagliptin in plasma.
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Timepoint [7]
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Week 12, 24 and 52
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Type 2 diabetes mellitus
2. GFR<60 ml/min
3. HbA1c >=7.0% to <= 10%
4. Age >= 18 years
5. BMI <=45 kg/m2
6. Signed and dated written informed consent
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Minimum age
18
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. Renal impairment requiring dialysis
3. Bariatric surgery
4. Impaired hepatic function
5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
6. Treatment with anti-obesity drugs
7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent
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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,SA,VIC
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Recruitment hospital [1]
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1218.64.61005 Boehringer Ingelheim Investigational Site - Gosford
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Recruitment hospital [2]
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1218.64.61001 Boehringer Ingelheim Investigational Site - Liverpool
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Recruitment hospital [3]
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1218.64.61002 Boehringer Ingelheim Investigational Site - St Leonards
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Recruitment hospital [4]
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1218.64.61003 Boehringer Ingelheim Investigational Site - Adelaide
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Recruitment hospital [5]
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1218.64.61004 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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- Liverpool
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Recruitment postcode(s) [3]
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- St Leonards
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Recruitment postcode(s) [4]
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- Adelaide
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Recruitment postcode(s) [5]
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- Reservoir
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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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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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Kokkola
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Finland
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Oulu
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Finland
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Turku
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Israel
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Ashkelon
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Israel
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Givatayim
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Tel Aviv
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Japan
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Asahi, Chiba
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Japan
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Isesaki, Gunma
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Japan
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Meguro-ku, Tokyo
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Japan
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Nagoya, Aichi
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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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Suita, Osaka
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Japan
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Suwa, Nagano
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New Zealand
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Otahuhu Auckland
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Nitra
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Slovakia
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Trencin
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Sweden
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Helsingborg
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Sweden
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State/province [37]
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Härnösand
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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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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 over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
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Trial website
https://clinicaltrials.gov/study/NCT01087502
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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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Email
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Contact person for public queries
Name
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Email
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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/NCT01087502
Download to PDF