Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01383356

First received: June 27, 2011

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Results First Received: December 18, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Metformin Single Tablet Drug: Linagliptin/Metformin Combo Drug: Linagliptin Single Tablet

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
18 subjects were enrolled in the original study (June 2011 to July 2011) and 40 in the add-on study (November 2011 to December 2011) which was an option provided by protocol to increase the subject number. As no significant STUDY and STUDY-by-TREATMENT effect was revealed in analysis of pooled data, final analysis was performed on pooled data.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a 2 period, 2 sequence, 2 treatment crossover. Subjects were randomized to one of the two sequences AB or BA. The duration of washout was at least 35 days between dosing.

Reporting Groups

	Description
Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg	Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg	Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg

Participant Flow for 3 periods

Period 1: Period 1

	Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg	Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg
STARTED	29 ^[1]	29 ^[1]
COMPLETED	21 ^[2]	23 ^[2]
NOT COMPLETED	8	6
Adverse Event	5	3
Non-compliance	3	0
Out of Range Mid-study-Test	0	1
Personal	0	2

[1]	Entered and treated.
[2]	Completed period 1.

Period 2: Washout Period (at Least 35 Days)

	Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg	Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg
STARTED	21	23
COMPLETED	21	23
NOT COMPLETED	0	0

Period 3: Period 2

	Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg	Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg
STARTED	21 ^[1]	23 ^[1]
COMPLETED	21 ^[2]	23 ^[2]
NOT COMPLETED	0	0

[1]	Entered and treated.
[2]	Completed period 2.

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Total number of subjects randomised and treated in the study.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	58
Age [units: years] Mean ± Standard Deviation	35 ± 9
Gender [units: Participants]
Female	32
Male	26

Outcome Measures

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1. Primary:

Maximum Plasma Concentration (Cmax) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]

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2. Primary:

Area Under the Curve 0 to Last Measurable Value (AUC0-t) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]

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3. Secondary:

Area Under the Curve 0 to Inf (AUC0-inf) [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]

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Serious Adverse Events

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Other Adverse Events

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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.

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.

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 Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01383356 History of Changes
Other Study ID Numbers:	1288.19
Study First Received:	June 27, 2011
Results First Received:	December 18, 2012
Last Updated:	December 18, 2012
Health Authority:	Canada: Health Canada

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