NCT01792518|CompletedPhase 3Results

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

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)

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

1218.892012-002603-17

Study Type

interventional

Target

360

Locations

12 countries

Sites

Timeline

RegisteredFeb 2013

StartedFeb 2013

CompletionDec 2015

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

360

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Feb 2013

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach

12 countries

74 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

February 1, 2013

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed

Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

February 14, 2013

Results QC Date

November 8, 2016

Last Update Submit

January 13, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
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.
Baseline and 24 weeks

Secondary Outcomes (2)

The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment
Baseline and 24 weeks
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment
Baseline and 24 weeks

Study Arms (2)

linagliptin 5mg

EXPERIMENTAL

linagliptin 5 mg once daily

Drug: Linagliptin 5mg

placebo

PLACEBO COMPARATOR

matching placebo for linagliptin dose once daily

Drug: Placebo

Interventions

PlaceboDRUG

placebo

Linagliptin 5mgDRUG

linagliptin 5mg

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.