We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01703286
First Posted: October 10, 2012
Last Update Posted: January 19, 2015
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Linagliptin
Drug: Glimepiride

  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
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
  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.
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 
Overall Participants Analyzed 
[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
  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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01703286     History of Changes
Other Study ID Numbers: 1218.105
2012-003317-33 ( EudraCT Number: EudraCT )
First Submitted: October 1, 2012
First Posted: October 10, 2012
Results First Submitted: January 12, 2015
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015



To Top