MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT01792518

First received: February 14, 2013

Last updated: January 13, 2017

Last verified: January 2017

History of Changes

Results First Received: November 8, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Placebo Drug: Linagliptin 5mg

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
360 patients were randomised and treated (Placebo: 178 patients, Linagliptin: 182 patients.)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized, double-blind, placebo controlled, parallel group study to evaluate glycemic and renal efficacy of once daily administration of Linagliptin 5 milligram (mg) for 24 weeks in type 2 diabetes patients, with micro- or macroalbuminuria on top of current treatment with Angiotensin Converting Enzyme inhibitor or Angiotensin Receptor Blocker

Reporting Groups

	Description
Placebo	Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
Linagliptin 5 mg	Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.

Participant Flow: Overall Study

	Placebo	Linagliptin 5 mg
STARTED	178	182
COMPLETED	170	175
NOT COMPLETED	8	7
Adverse Event	3	4
Protocol Violation	0	1
Lost to Follow-up	3	1
Withdrawal by Subject	2	0
Other Reason	0	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.
Treated Set (TS) - including all patients treated with at least one dose of randomised trial medication.

Reporting Groups

	Description
Placebo	Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
Linagliptin 5 mg	Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Linagliptin 5 mg	Total
Overall Participants Analyzed [Units: Participants]	178	182	360

Age [Units: Years] Mean (Standard Deviation)	60.1 (9.3)	61.0 (10.0)	60.6 (9.6)

Gender [Units: Participants] Count of Participants
Female	65 36.5%	66 36.3%	131 36.4%
Male	113 63.5%	116 63.7%	229 63.6%

Outcome Measures

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1. Primary:

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment [ Time Frame: Baseline and 24 weeks ]

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2. Secondary:

The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]

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3. Secondary:

The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment [ Time Frame: Baseline and 24 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: Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.

Results Point of Contact:

Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

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

Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, von Eynatten M. Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial. Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01792518 History of Changes
Other Study ID Numbers:	1218.89 2012-002603-17 ( EudraCT Number: EudraCT )
Study First Received:	February 14, 2013
Results First Received:	November 8, 2016
Last Updated:	January 13, 2017

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