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

Tracking Information

First Received Date ^ICMJE

February 14, 2013

Last Updated Date

January 13, 2017

Start Date ^ICMJE

February 2013

Primary Completion Date

November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double- blind trial medication. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.

Original Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c [ Time Frame: 24 weeks ]

Change History

Complete list of historical versions of study NCT01792518 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]
The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term "baseline" for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means.
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]
The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term "baseline" refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint.

Original Secondary Outcome Measures ^ICMJE

The time weighted average of percentage change from baseline in UACR [ Time Frame: 24 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

Brief Summary

Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Placebo
Drug: Linagliptin 5mg

Study Arms

Experimental: linagliptin 5mg
linagliptin 5 mg once daily

Intervention: Drug: Linagliptin 5mg
Placebo Comparator: placebo
matching placebo for linagliptin dose once daily

Intervention: Drug: Placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

360

Completion Date

December 2015

Primary Completion Date

November 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Diagnosis of type 2 diabetes mellitus
Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)
Current therapy with ACEi or ARB at stable dose for 10 weeks
Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.
Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.
Age between 18 and 80 years.

Exclusion criteria:

Dual or triple blockade of the Renin Angiotensin System (RAS)
Uncontrolled hyperglycaemia
Mean arterial blood pressure > 110 mmHg
Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).
Treatment with a glitazone within 6 months prior to informed consent.
Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent.
Treatment with anti-obesity drugs 10 weeks prior to informed consent.
Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Participation in another trial with an investigational drug within 2 months prior to informed consent.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, Denmark, Finland, France, Germany, Japan, Korea, Republic of, Philippines, Spain, Taiwan, United States, Vietnam

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01792518

Other Study ID Numbers ^ICMJE

1218.89
2012-002603-17 ( EudraCT Number: EudraCT )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

PRS Account

Boehringer Ingelheim

Verification Date

January 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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