Diabetes Mellitus, Type 2Phase 3NCT01792518

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

A Phase 3 study testing Linagliptin 5mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 74 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Linagliptin 5mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 74 sitesin 12 countries
Study dates: Feb 2013to Dec 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

74 sites in 12 countries.

Country

City, postcode or hospital

74 sites in 12 countries

United States15 sites

Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
Boehringer Ingelheim Investigational Site
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
Boehringer Ingelheim Investigational Site
Columbus, Ohio
Boehringer Ingelheim Investigational Site
Denver, Colorado
Boehringer Ingelheim Investigational Site
Evansville, Indiana
Boehringer Ingelheim Investigational Site
Fargo, North Dakota
Boehringer Ingelheim Investigational Site
Flint, Michigan
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Jackson, Mississippi
Boehringer Ingelheim Investigational Site
Knoxville, Tennessee
Boehringer Ingelheim Investigational Site
Long Beach, California
Boehringer Ingelheim Investigational Site
Miami, Florida
Boehringer Ingelheim Investigational Site
North Hollywood, California
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma

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Canada8 sites

Boehringer Ingelheim Investigational Site
Edmonton, Alberta
Boehringer Ingelheim Investigational Site
London, Ontario
Boehringer Ingelheim Investigational Site
Mississauga, Ontario
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
Sarnia, Ontario
Boehringer Ingelheim Investigational Site
Toronto, Ontario
Boehringer Ingelheim Investigational Site
Victoria, British Columbia
Boehringer Ingelheim Investigational Site
Waterloo, Ontario

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France8 sites

Boehringer Ingelheim Investigational Site
Bersée
Boehringer Ingelheim Investigational Site
Bourg-des-Comptes
Boehringer Ingelheim Investigational Site
Grenoble
Boehringer Ingelheim Investigational Site
Le Creusot
Boehringer Ingelheim Investigational Site
Marseille
Boehringer Ingelheim Investigational Site
Saint-Mandé
Boehringer Ingelheim Investigational Site
Vénissieux
Boehringer Ingelheim Investigational Site
Vieux-Condé

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Germany7 sites

Boehringer Ingelheim Investigational Site
Aschaffenburg
Boehringer Ingelheim Investigational Site
Aßlar
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Flörsheim
Boehringer Ingelheim Investigational Site
Pirna
Boehringer Ingelheim Investigational Site
Schweinfurt

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Japan7 sites

Boehringer Ingelheim Investigational Site
Aoba-ku,Sendai,Miyagi
Boehringer Ingelheim Investigational Site
Chiyoda-ku,Tokyo
Boehringer Ingelheim Investigational Site
Cyuo-ku,Tokyo
Boehringer Ingelheim Investigational Site
Kita-ku, Osaka, Osaka
Boehringer Ingelheim Investigational Site
Shimizu-ku,Shizuoka city,Shizuoka
Boehringer Ingelheim Investigational Site
Suita,Osaka
Boehringer Ingelheim Investigational Site
Teine-ku,Sapporo,Hokkaido

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Taiwan6 sites

Boehringer Ingelheim Investigational Site
Changhua
Boehringer Ingelheim Investigational Site
Kaohsiung City
Boehringer Ingelheim Investigational Site
New Taipei City
Boehringer Ingelheim Investigational Site
Taichung
Boehringer Ingelheim Investigational Site
Tainan
Boehringer Ingelheim Investigational Site
Taipei

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South Korea5 sites

Boehringer Ingelheim Investigational Site
Goyang
Boehringer Ingelheim Investigational Site
Jinju
Boehringer Ingelheim Investigational Site
Seongnam
Boehringer Ingelheim Investigational Site
Seoul
Boehringer Ingelheim Investigational Site
Wŏnju

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Spain5 sites

Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
Boehringer Ingelheim Investigational Site
Madrid
Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón
Boehringer Ingelheim Investigational Site
San Sebastián de los Reyes
Boehringer Ingelheim Investigational Site
Valencia

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Denmark4 sites

Boehringer Ingelheim Investigational Site
Gentofte Municipality
Boehringer Ingelheim Investigational Site
Hillerød
Boehringer Ingelheim Investigational Site
Silkeborg
Boehringer Ingelheim Investigational Site
Slagelse

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Finland4 sites

Boehringer Ingelheim Investigational Site
Kerava
Boehringer Ingelheim Investigational Site
Oulu
Boehringer Ingelheim Investigational Site
Tampere
Boehringer Ingelheim Investigational Site
Turku

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Philippines3 sites

Boehringer Ingelheim Investigational Site
Cebu City, Philippines
Boehringer Ingelheim Investigational Site
Pasig City, Philippines
Boehringer Ingelheim Investigational Site
San Juan City, Philippines

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Vietnam2 sites

Boehringer Ingelheim Investigational Site
Hanoi, Vietnam
Boehringer Ingelheim Investigational Site
Ho Chi Minh City

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About this study

Official title: 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)

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, Linagliptin 5mg
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Linagliptin 5mgDrug

Study groups in NCT01792518
Study group	Role	What they receive
linagliptin 5mg	Experimental	linagliptin 5 mg once daily Receives: Drug: Linagliptin 5mg
placebo	Placebo comparator	matching placebo for linagliptin dose once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Baseline and 24 weeks
The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment
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.
Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Dec 2015

First posted15 Feb 2013 (estimated)
Study startFeb 2013
Primary completionNov 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01792518
Sponsor's protocol ID: 1218.89
Other IDs: 2012-002603-17
Status last verified: Jan 2017
First submitted: 14 Feb 2013
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.
PubMed 30632692
Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.
PubMed 28636754
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.
PubMed 26224765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01792518
Acronym / sponsor ID: 1218.89
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Feb 2013
Primary completion: Nov 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 15 Feb 2013 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
linagliptin 5mg	Experimental	Drug: Linagliptin 5mglinagliptin 5 mg once daily
placebo	Placebo comparator	Drug: Placebomatching placebo for linagliptin dose once daily

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo	Drug	placebo
Linagliptin 5mg	Drug	linagliptin 5mg

Primary outcome

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.

2 secondary outcomes

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 Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 6 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	178	170
Linagliptin 5 mg	182	175

Primary outcome: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment

Time frame: Baseline and 24 weeks. Least squares mean (Standard Error). Unit: Percentage of HbA1c

Measure	Placebo n = 156	Linagliptin 5 mg n = 161
Value	-0.03 (0.06)	-0.63 (0.06)

Placebo vs Linagliptin 5 mg: Mean Difference (Final Values): -0.60 (95% CI -0.78 to -0.43), p <0.0001, Mixed Models Analysis

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after the last drug administration, up to 240 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	8 of 178 (4.5%)	27 of 178 (15.2%)	Not reported
Linagliptin 5 mg	17 of 182 (9.3%)	39 of 182 (21.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30632692Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.
Derived from this study: PubMed 28636754Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.
Derived from this study: PubMed 26224765Groop 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

74 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin 5mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 74 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Canada, France, Germany, Japan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01792518, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.