Phase 3 N=360 Randomized Double-blind Treatment

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

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT01792518 ↗

Enrolled (actual)

360

Serious AEs

6.9%

Results posted

Mar 2017

Primary outcome: Primary: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment — -0.03; -0.63 Percentage of HbA1c — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Drug); Linagliptin 5mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2015

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

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01792518). 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.