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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/NCT00800683
Registration number
NCT00800683
Ethics application status
Date submitted
1/12/2008
Date registered
2/12/2008
Date last updated
20/05/2014
Titles & IDs
Public title
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
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Scientific title
Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
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Secondary ID [1]
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2008-001569-27
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Secondary ID [2]
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1218.43
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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
Renal and Urogenital
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Other renal and urogenital disorders
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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 - BI 1356
Treatment: Drugs - placebo
Experimental: BI 1356 - patient to receive a tablet containing BI 1356 once daily
Placebo Comparator: placebo - patient to receive a tablet identical to BI 1356 once daily
Treatment: Drugs: BI 1356
BI 1356 dosed once daily
Treatment: Drugs: placebo
placebo matching BI 1356 taken 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 12
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Assessment method [1]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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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 at Week 52
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Assessment method [1]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [2]
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HbA1c Change From Baseline at Week 18
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Assessment method [2]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [2]
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Baseline and Week 18
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Secondary outcome [3]
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HbA1c Change From Baseline at Week 24
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Assessment method [3]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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HbA1c Change From Baseline at Week 30
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Assessment method [4]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [4]
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Baseline and Week 30
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Secondary outcome [5]
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HbA1c Change From Baseline at Week 36
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Assessment method [5]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [5]
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Baseline and Week 36
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Secondary outcome [6]
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HbA1c Change From Baseline at Week 42
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Assessment method [6]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [6]
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Baseline and Week 42
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Secondary outcome [7]
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HbA1c Change From Baseline at Week 48
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Assessment method [7]
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HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
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Timepoint [7]
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Baseline and Week 48
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Secondary outcome [8]
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The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
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Assessment method [8]
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The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
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Timepoint [8]
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Baseline and Week 52
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Secondary outcome [9]
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The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
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Assessment method [9]
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The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
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Timepoint [9]
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Baseline and Week 52
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Secondary outcome [10]
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Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
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Assessment method [10]
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The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
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Timepoint [10]
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Baseline and Week 52
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Secondary outcome [11]
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FPG Change From Baseline at Week 12
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Assessment method [11]
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This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
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Timepoint [11]
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Baseline and Week 12
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Secondary outcome [12]
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FPG Change From Baseline at Week 18
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Assessment method [12]
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Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
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Timepoint [12]
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Baseline and Week 18
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Secondary outcome [13]
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FPG 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 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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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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FPG Change From Baseline at Week 30
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Assessment method [14]
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This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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Timepoint [14]
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Baseline and Week 30
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Secondary outcome [15]
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FPG Change From Baseline at Week 36
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Assessment method [15]
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This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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Timepoint [15]
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Baseline and Week 36
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Secondary outcome [16]
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FPG Change From Baseline at Week 42
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Assessment method [16]
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This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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Timepoint [16]
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Baseline and Week 42
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Secondary outcome [17]
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FPG Change From Baseline at Week 48
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Assessment method [17]
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This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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Timepoint [17]
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Baseline and Week 48
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Secondary outcome [18]
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FPG Change From Baseline at week52
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Assessment method [18]
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This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
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Timepoint [18]
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Baseline and Week 52
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Secondary outcome [19]
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Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
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Assessment method [19]
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Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
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Timepoint [19]
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Baseline and Week 52
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Secondary outcome [20]
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Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
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Assessment method [20]
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Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
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Timepoint [20]
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first administration of randomised treatment to ....
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Male and female patients with type 2 diabetes and with glomerular filtration rate
(GFR) <30 ml/min, who are not on chronic dialysis.
- Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
- Age 18 or over and not older than 80 years
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Minimum age
18
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Maximum age
80
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:
- Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea
within 3 months prior to informed consent
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior
to informed consent
- Unstable or acute congestive heart failure
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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
1/12/2008
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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
133
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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1218.43.61009 Boehringer Ingelheim Investigational Site - Gosford
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Recruitment hospital [2]
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1218.43.61010 Boehringer Ingelheim Investigational Site - Auchenflower
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Recruitment hospital [3]
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1218.43.61006 Boehringer Ingelheim Investigational Site - Kippa Ring
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Recruitment hospital [4]
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1218.43.61007 Boehringer Ingelheim Investigational Site - Reservoir
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Recruitment hospital [5]
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1218.43.61011 Boehringer Ingelheim Investigational Site - Richmond
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Recruitment hospital [6]
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1218.43.61005 Boehringer Ingelheim Investigational Site - Adelaide, SA
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Recruitment hospital [7]
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1218.43.61002 Boehringer Ingelheim Investigational Site - Herston, QLD
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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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- Auchenflower
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Recruitment postcode(s) [3]
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- Kippa Ring
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Recruitment postcode(s) [4]
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- Reservoir
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Recruitment postcode(s) [5]
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- Richmond
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Recruitment postcode(s) [6]
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- Adelaide, SA
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Recruitment postcode(s) [7]
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- Herston, QLD
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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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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Louisiana
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Ohio
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Country [11]
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
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United States of America
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State/province [12]
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Rhode Island
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Country [13]
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United States of America
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State/province [13]
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South Carolina
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Country [14]
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United States of America
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State/province [14]
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Texas
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Country [15]
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United States of America
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State/province [15]
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Washington
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Country [16]
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Hong Kong
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State/province [16]
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Hong Kong
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Country [17]
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Hong Kong
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State/province [17]
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New Territories
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Country [18]
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Israel
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State/province [18]
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Afula
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Country [19]
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Israel
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State/province [19]
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Ashkelon
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Country [20]
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Israel
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State/province [20]
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Haifa
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Country [21]
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Israel
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State/province [21]
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Jerusalem
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Country [22]
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Israel
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State/province [22]
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Kfar Saba
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Country [23]
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Israel
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State/province [23]
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Nahariya
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Country [24]
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Israel
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State/province [24]
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Safed
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Country [25]
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Israel
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State/province [25]
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Tel Aviv
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Country [26]
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New Zealand
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State/province [26]
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Auckland
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Country [27]
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New Zealand
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State/province [27]
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Christchurch
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Country [28]
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New Zealand
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State/province [28]
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Takpuna
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Country [29]
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New Zealand
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State/province [29]
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Tauranga
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Country [30]
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Ukraine
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State/province [30]
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Kharkiv
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Country [31]
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Ukraine
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State/province [31]
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Kharkov
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Country [32]
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Ukraine
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State/province [32]
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Kiev
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Country [33]
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Ukraine
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State/province [33]
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Lugansk
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Country [34]
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Ukraine
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State/province [34]
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Ternopil
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Country [35]
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Ukraine
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State/province [35]
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Zaporizhzhya
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00800683
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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/NCT00800683
Download to PDF