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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Linagliptin 5mg

• Registration Number: NCT01792518
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Results First Submitted: 2016-11-08
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	matching placebo for linagliptin dose once daily
linagliptin 5mg	Linagliptin 5mg	linagliptin 5 mg once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇻🇳 Ho Chi Minh City, Vietnam