Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00800683
First received: December 1, 2008
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: December 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 1356
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Hide Baseline Characteristics

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.
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
Total Total of all reporting groups

Baseline Measures
    Placebo     Linagliptin (BI 1356)     Total  
Number of Participants  
[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  
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  
Body Mass Index (BMI) Continuous  
[units: kg/m²]
Mean ± Standard Deviation
  31.7  ± 5.9     32.3  ± 5.9     32.0  ± 5.8  
[1] Described in the patients of the Full Analysis Set : 62 in placebo group versus 66 in Linagliptin group



  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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00800683     History of Changes
Other Study ID Numbers: 1218.43, 2008-001569-27
Study First Received: December 1, 2008
Results First Received: December 30, 2011
Last Updated: May 15, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Hong Kong: Department of Health
Israel: Ministry of Health
New Zealand: Medsafe
Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine
United States: Food and Drug Administration