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

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ClinicalTrials.gov Identifier: NCT01792518
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

  Participant Flow

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

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

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

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 ]

3.  Secondary:   The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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
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: NCT01792518     History of Changes
Other Study ID Numbers: 1218.89
2012-002603-17 ( EudraCT Number: EudraCT )
First Submitted: February 14, 2013
First Posted: February 15, 2013
Results First Submitted: November 8, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017