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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800683
First Posted: December 2, 2008
Last Update Posted: May 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: December 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 1356
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Patients randomized to receive treatment with matching placebo
Linagliptin (BI 1356) Patients randomized to receive treatment with Linagliptin 5mg

Participant Flow:   Overall Study
    Placebo   Linagliptin (BI 1356)
STARTED   65 [1]   68 [1] 
COMPLETED   48 [2]   49 [2] 
NOT COMPLETED   17   19 
Adverse Event                11                8 
Lost to Follow-up                3                1 
Withdrawal by Subject                1                7 
Lack of Efficacy                1                1 
Not specified                1                2 
[1] Number who started treatment
[2] Number who completed treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Patients randomized to receive treatment with matching placebo
Linagliptin (BI 1356) Patients randomized to receive treatment with Linagliptin 5mg
Total Total of all reporting groups

Baseline Measures
   Placebo   Linagliptin (BI 1356)   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   68   133 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (9.6)   64.0  (10.9)   64.4  (10.3) 
Gender 
[Units: Participants]
     
Female   30   23   53 
Male   35   45   80 
Glycosylated haemoglobin (HbA1c) at baseline [1] 
[Units: Percentage]
Mean (Standard Deviation)
 8.2  (0.9)   8.2  (1.1)   8.2  (1.0) 
[1] Described in the patients of the Full Analysis Set : 62 in placebo group versus 66 in Linagliptin group
Fasting plasma glucose (FPG) at baseline [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 160.1  (65.4)   149.5  (79.5)   154.6  (72.9) 
[1] Described in the patients of the Full Analysis Set : 62 in placebo group versus 66 in Linagliptin group
Body Mass Index (BMI) Continuous 
[Units: Kg/m²]
Mean (Standard Deviation)
 31.7  (5.9)   32.3  (5.9)   32.0  (5.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c Change From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   HbA1c Change From Baseline at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   HbA1c Change From Baseline at Week 18   [ Time Frame: Baseline and Week 18 ]

4.  Secondary:   HbA1c Change From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   HbA1c Change From Baseline at Week 30   [ Time Frame: Baseline and Week 30 ]

6.  Secondary:   HbA1c Change From Baseline at Week 36   [ Time Frame: Baseline and Week 36 ]

7.  Secondary:   HbA1c Change From Baseline at Week 42   [ Time Frame: Baseline and Week 42 ]

8.  Secondary:   HbA1c Change From Baseline at Week 48   [ Time Frame: Baseline and Week 48 ]

9.  Secondary:   The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment   [ Time Frame: Baseline and Week 52 ]

10.  Secondary:   The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment   [ Time Frame: Baseline and Week 52 ]

11.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% at Week 52   [ Time Frame: Baseline and Week 52 ]

12.  Secondary:   FPG Change From Baseline at Week 12   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   FPG Change From Baseline at Week 18   [ Time Frame: Baseline and Week 18 ]

14.  Secondary:   FPG Change From Baseline at Week 24   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:   FPG Change From Baseline at Week 30   [ Time Frame: Baseline and Week 30 ]

16.  Secondary:   FPG Change From Baseline at Week 36   [ Time Frame: Baseline and Week 36 ]

17.  Secondary:   FPG Change From Baseline at Week 42   [ Time Frame: Baseline and Week 42 ]

18.  Secondary:   FPG Change From Baseline at Week 48   [ Time Frame: Baseline and Week 48 ]

19.  Secondary:   FPG Change From Baseline at week52   [ Time Frame: Baseline and Week 52 ]

20.  Secondary:   Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time   [ Time Frame: Baseline and Week 52 ]

21.  Secondary:   Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG   [ Time Frame: first administration of randomised treatment to .... ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00800683     History of Changes
Other Study ID Numbers: 1218.43
2008-001569-27 ( EudraCT Number: EudraCT )
First Submitted: December 1, 2008
First Posted: December 2, 2008
Results First Submitted: December 30, 2011
Results First Posted: February 1, 2012
Last Update Posted: May 20, 2014