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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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 ]

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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 ]

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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 ]

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01703286 History of Changes
Other Study ID Numbers:	1218.105 2012-003317-33 ( EudraCT Number: EudraCT )
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

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