Status:
COMPLETED
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01792518
Start Date
February 1 2013
End Date
December 1 2015
Last Update
March 6 2017
Active Locations (74)
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1
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
3
Boehringer Ingelheim Investigational Site
North Hollywood, California, United States
4
Boehringer Ingelheim Investigational Site
Denver, Colorado, United States