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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01792518
First received: February 14, 2013
Last updated: January 6, 2016
Last verified: January 2016

February 14, 2013
January 6, 2016
February 2013
November 2015   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01792518 on ClinicalTrials.gov Archive Site
The time weighted average of percentage change from baseline in UACR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
  • Drug: Linagliptin 5mg
  • Experimental: linagliptin 5mg
    linagliptin 5 mg once daily
    Intervention: Drug: Linagliptin 5mg
  • Placebo Comparator: placebo
    matching placebo for linagliptin dose once daily
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
December 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Finland,   France,   Germany,   Japan,   Korea, Republic of,   Philippines,   Spain,   Taiwan,   Vietnam
 
NCT01792518
1218.89, 2012-002603-17
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP