Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01703286
First received: October 1, 2012
Last updated: January 12, 2015
Last verified: January 2015
Results First Received: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Linagliptin
Drug: Glimepiride

  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
No text entered.

Reporting Groups
  Description
Pbo/ G1-4/ L 5 Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
L 5/ G 1-4/ Pbo Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
G 1-4/ L 5/ Pbo Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
G1-4/ Pbo/ L 5 Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
Pbo/ L 5/ G1-4 Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
L 5/ Pbo/ G1-4/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days

Participant Flow for 3 periods

Period 1:   Period 1 Including Washout
    Pbo/ G1-4/ L 5     L 5/ G 1-4/ Pbo     G 1-4/ L 5/ Pbo     G1-4/ Pbo/ L 5     Pbo/ L 5/ G1-4     L 5/ Pbo/ G1-4/  
STARTED     7     7     7     7     7     7  
COMPLETED     7     7     7     6     7     6  
NOT COMPLETED     0     0     0     1     0     1  
Withdrawal by Subject                 0                 0                 0                 1                 0                 1  

Period 2:   Period 2 Including Washout
    Pbo/ G1-4/ L 5     L 5/ G 1-4/ Pbo     G 1-4/ L 5/ Pbo     G1-4/ Pbo/ L 5     Pbo/ L 5/ G1-4     L 5/ Pbo/ G1-4/  
STARTED     7     7     7     6     7     6  
COMPLETED     7     7     7     5     7     6  
NOT COMPLETED     0     0     0     1     0     0  
Adverse Event                 0                 0                 0                 1                 0                 0  

Period 3:   Period 3 Including Washout
    Pbo/ G1-4/ L 5     L 5/ G 1-4/ Pbo     G 1-4/ L 5/ Pbo     G1-4/ Pbo/ L 5     Pbo/ L 5/ G1-4     L 5/ Pbo/ G1-4/  
STARTED     7     7     7     5     7     6  
COMPLETED     7     7     7     5     7     6  
NOT COMPLETED     0     0     0     0     0     0  



  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.
TS (treated set) - included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial drug.

Reporting Groups
  Description
Total Participants All study participants

Baseline Measures
    Total Participants  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Mean ± Standard Deviation
  60.3  ± 6.0  
Gender  
[units: participants]
 
Female     14  
Male     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28   [ Time Frame: baseline and day 28 for each treatment arm ]

2.  Secondary:   Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28   [ Time Frame: baseline and day 28 for each treatment arm ]

3.  Secondary:   Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28   [ Time Frame: baseline and day 28 for each treatment arm ]

4.  Secondary:   Number of Patients With Adverse Events   [ Time Frame: up to 20 weeks ]


  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
No text entered.


  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


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01703286     History of Changes
Other Study ID Numbers: 1218.105, 2012-003317-33
Study First Received: October 1, 2012
Results First Received: January 12, 2015
Last Updated: January 12, 2015
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection