Phase 3
Completed N=360
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Source: ClinicalTrials.gov NCT01792518 ↗Enrolled (actual)
360
Serious AEs
6.9%
Results posted
Mar 2017
Primary outcomePrimary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment — -0.03; -0.63 Percentage of HbA1c — p=<0.0001
◆ Published Evidence
Highly cited
152citations · ~17 / year
Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D 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.
Linked Publications (3)
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Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial.
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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.
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Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment |
-0.03; -0.63 | <0.0001 sig |
| SECONDARY The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment |
0.9487; 0.8902 | 0.1954 |
| SECONDARY The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment |
-2.35; -4.98 | 0.3306 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01792518) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.