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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2008-001569-27
Secondary ID [2] 0 0
1218.43
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c Change From Baseline at Week 12 - 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.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
HbA1c Change From Baseline at Week 52 - 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.
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
HbA1c Change From Baseline at Week 18 - 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.
Timepoint [2] 0 0
Baseline and Week 18
Secondary outcome [3] 0 0
HbA1c Change From Baseline at Week 24 - 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.
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
HbA1c Change From Baseline at Week 30 - 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.
Timepoint [4] 0 0
Baseline and Week 30
Secondary outcome [5] 0 0
HbA1c Change From Baseline at Week 36 - 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.
Timepoint [5] 0 0
Baseline and Week 36
Secondary outcome [6] 0 0
HbA1c Change From Baseline at Week 42 - 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.
Timepoint [6] 0 0
Baseline and Week 42
Secondary outcome [7] 0 0
HbA1c Change From Baseline at Week 48 - 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.
Timepoint [7] 0 0
Baseline and Week 48
Secondary outcome [8] 0 0
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment - 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%
Timepoint [8] 0 0
Baseline and Week 52
Secondary outcome [9] 0 0
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment - 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%.
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 - 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).
Timepoint [10] 0 0
Baseline and Week 52
Secondary outcome [11] 0 0
FPG Change From Baseline at Week 12 - 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
Timepoint [11] 0 0
Baseline and Week 12
Secondary outcome [12] 0 0
FPG Change From Baseline at Week 18 - Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Timepoint [12] 0 0
Baseline and Week 18
Secondary outcome [13] 0 0
FPG Change From Baseline at Week 24 - 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
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
FPG Change From Baseline at Week 30 - 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
Timepoint [14] 0 0
Baseline and Week 30
Secondary outcome [15] 0 0
FPG Change From Baseline at Week 36 - 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
Timepoint [15] 0 0
Baseline and Week 36
Secondary outcome [16] 0 0
FPG Change From Baseline at Week 42 - 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
Timepoint [16] 0 0
Baseline and Week 42
Secondary outcome [17] 0 0
FPG Change From Baseline at Week 48 - 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
Timepoint [17] 0 0
Baseline and Week 48
Secondary outcome [18] 0 0
FPG Change From Baseline at week52 - 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
Timepoint [18] 0 0
Baseline and Week 52
Secondary outcome [19] 0 0
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time - Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Timepoint [19] 0 0
Baseline and Week 52
Secondary outcome [20] 0 0
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG - 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.
Timepoint [20] 0 0
first administration of randomised treatment to ....

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
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
1218.43.61009 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
1218.43.61010 Boehringer Ingelheim Investigational Site - Auchenflower
Recruitment hospital [3] 0 0
1218.43.61006 Boehringer Ingelheim Investigational Site - Kippa Ring
Recruitment hospital [4] 0 0
1218.43.61007 Boehringer Ingelheim Investigational Site - Reservoir
Recruitment hospital [5] 0 0
1218.43.61011 Boehringer Ingelheim Investigational Site - Richmond
Recruitment hospital [6] 0 0
1218.43.61005 Boehringer Ingelheim Investigational Site - Adelaide, SA
Recruitment hospital [7] 0 0
1218.43.61002 Boehringer Ingelheim Investigational Site - Herston, QLD
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
- Kippa Ring
Recruitment postcode(s) [4] 0 0
- Reservoir
Recruitment postcode(s) [5] 0 0
- Richmond
Recruitment postcode(s) [6] 0 0
- Adelaide, SA
Recruitment postcode(s) [7] 0 0
- Herston, QLD
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Hong Kong
Country [17] 0 0
Hong Kong
State/province [17] 0 0
New Territories
Country [18] 0 0
Israel
State/province [18] 0 0
Afula
Country [19] 0 0
Israel
State/province [19] 0 0
Ashkelon
Country [20] 0 0
Israel
State/province [20] 0 0
Haifa
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Kfar Saba
Country [23] 0 0
Israel
State/province [23] 0 0
Nahariya
Country [24] 0 0
Israel
State/province [24] 0 0
Safed
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Takpuna
Country [29] 0 0
New Zealand
State/province [29] 0 0
Tauranga
Country [30] 0 0
Ukraine
State/province [30] 0 0
Kharkiv
Country [31] 0 0
Ukraine
State/province [31] 0 0
Kharkov
Country [32] 0 0
Ukraine
State/province [32] 0 0
Kiev
Country [33] 0 0
Ukraine
State/province [33] 0 0
Lugansk
Country [34] 0 0
Ukraine
State/province [34] 0 0
Ternopil
Country [35] 0 0
Ukraine
State/province [35] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Trial website
https://clinicaltrials.gov/show/NCT00800683
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications