Trial · NCT01792518

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

NCT01792518, Phase 3, Completed, Boehringer Ingelheim; results first posted 2017-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin. Trials, record NCT01792518. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01792518

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
NCT number: NCT01792518
Status: Completed
Phases: Phase 3
Enrollment: 360 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Diabetes Mellitus, Type 2
Interventions: Placebo, Linagliptin 5mg
First posted: 2013-02-15
Last updated: 2017-03-06
Other registries' IDs: eudract:2012-002603-17
Results first posted: 2017-03-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment	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.
Secondary	The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment	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.
Secondary	The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment	Baseline and 24 weeks	Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Observed Case (OC): Values after the use of rescue medication were set to missing.	Percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment	Baseline and 24 weeks	Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Last Observation Carried Forward (LOCF).	mg/g creatinine	LEAST_SQUARES_MEAN
SECONDARY	The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment	Baseline and 24 weeks	Treated Set	milliliter/minute/1.73 square metre	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment	Placebo	-0.03	Standard Error 0.06	Percentage of HbA1c
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment	Linagliptin 5 mg	-0.63	Standard Error 0.06	Percentage of HbA1c
The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment	Placebo	0.9487	95% Confidence Interval 0.06	mg/g creatinine
The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment	Linagliptin 5 mg	0.8902	95% Confidence Interval 0.06	mg/g creatinine
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment	Placebo	-2.35	Standard Error 1.92	milliliter/minute/1.73 square metre
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment	Linagliptin 5 mg	-4.98	Standard Error 1.89	milliliter/minute/1.73 square metre

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	178
Overall Study	STARTED	Linagliptin 5 mg	182
Overall Study	COMPLETED	Placebo	170
Overall Study	COMPLETED	Linagliptin 5 mg	175
Overall Study	NOT COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Linagliptin 5 mg	7

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Placebo	10	178
other	Nasopharyngitis	Infections and infestations	Linagliptin 5 mg	13	182
other	Upper respiratory tract infection	Infections and infestations	Placebo	9	178
other	Upper respiratory tract infection	Infections and infestations	Linagliptin 5 mg	4	182
other	Hypoglycaemia	Metabolism and nutrition disorders	Placebo	10	178
other	Hypoglycaemia	Metabolism and nutrition disorders	Linagliptin 5 mg	24	182
serious	Acute myocardial infarction	Cardiac disorders	Placebo	0	178
serious	Acute myocardial infarction	Cardiac disorders	Linagliptin 5 mg	1	182
serious	Cardiac failure	Cardiac disorders	Placebo	0	178
serious	Cardiac failure	Cardiac disorders	Linagliptin 5 mg	1	182

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Linagliptin 5 mg
Total, other adverse events	Placebo	27	178
Total, other adverse events	Linagliptin 5 mg	39	182
Total, serious adverse events	Placebo	8	178
Total, serious adverse events	Linagliptin 5 mg	17	182

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26224765	DERIVED	PubMed
28636754	DERIVED	PubMed
30632692	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Linagliptin 5 mg vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01792518

GET https://conductscience.org/api/trials/v1/NCT01792518/events?page=2

API reference For AI assistants