Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01084005
First received: March 9, 2010
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: linagliptin
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 241 patients were randomised in a 2:1 ratio to receive treatment with linagliptin 5mg (n=162) or placebo (n=79). All randomised patients were treated.

Reporting Groups
  Description
Placebo Patients randomized to receive treatment with matching placebo
Linagliptin 5 mg Patients randomized to receive treatment with Linagliptin 5mg

Participant Flow:   Overall Study
    Placebo     Linagliptin 5 mg  
STARTED     79     162  
COMPLETED     74     146  
NOT COMPLETED     5     16  
Adverse Event                 1                 8  
Protocol Violation                 3                 7  
Withdrawal by Subject                 1                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo Patients randomized to receive treatment with matching placebo
Linagliptin 5 mg Patients randomized to receive treatment with Linagliptin 5mg
Total Total of all reporting groups

Baseline Measures
    Placebo     Linagliptin 5 mg     Total  
Number of Participants  
[units: participants]
  79     162     241  
Age  
[units: Years]
Mean ± Standard Deviation
  74.9  ± 4.2     74.9  ± 4.4     74.9  ± 4.3  
Gender  
[units: Number]
     
Female     30     46     76  
Male     49     116     165  
Body mass index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation
  29.80  ± 4.54     29.60  ± 4.74     29.67  ± 4.67  
Glycosylated Hemoglobin A1 (HbA1c) [1]
[units: Percent]
Mean ± Standard Deviation
  7.70  ± 0.70     7.82  ± 0.78     7.78  ± 0.76  
Fasting Plasma Glucose (FPG) [2]
[units: mg/dL]
Mean ± Standard Deviation
  144.1  ± 29.6     152.7  ± 28.7     149.9  ± 29.2  
[1] Based upon the full analysis set (FAS) with 78 and 160 patients
[2] Based upon the FAS with 78 and 160 patients



  Outcome Measures
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1.  Primary:   HbA1c Change From Baseline to Week 24   [ Time Frame: Baseline and week 24 ]

2.  Secondary:   HbA1c Change From Baseline to Week 6   [ Time Frame: Baseline and week 6 ]

3.  Secondary:   HbA1c Change From Baseline to Week 12   [ Time Frame: Baseline and week 12 ]

4.  Secondary:   HbA1c Change From Baseline to Week 18   [ Time Frame: Baseline and week 18 ]

5.  Secondary:   FPG Change From Baseline to Week 24   [ Time Frame: Baseline and week 24 ]

6.  Secondary:   FPG Change From Baseline to Week 6   [ Time Frame: Baseline and week 6 ]

7.  Secondary:   FPG Change From Baseline to Week 12   [ Time Frame: Baseline and week 12 ]

8.  Secondary:   FPG Change From Baseline to Week 18   [ Time Frame: Baseline and week 18 ]

9.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 24   [ Time Frame: Baseline and week 24 ]

10.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 24   [ Time Frame: Baseline and week 24 ]

11.  Secondary:   Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24   [ Time Frame: Baseline and week 24 ]

12.  Secondary:   Number of Patients With Rescue Therapy   [ Time Frame: week 24 ]


  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


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01084005     History of Changes
Other Study ID Numbers: 1218.63, 2009-015255-25
Study First Received: March 9, 2010
Results First Received: June 14, 2012
Last Updated: December 11, 2013
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Canada: Health Canada
Denmark: Danish Medicines Agency
Netherlands: Central Committee Research Involving Human Subjects
Sweden: Medical Products Agency