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MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
This study has been completed.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01792518
First received: February 14, 2013
Last updated: January 13, 2017
Last verified: January 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Placebo Drug: Linagliptin 5mg | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment [ Time Frame: 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:
- The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment [ Time Frame: 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 [ Time Frame: 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.
| Enrollment: | 360 |
| Study Start Date: | February 2013 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: linagliptin 5mg
linagliptin 5 mg once daily
|
Drug: Linagliptin 5mg |
|
Placebo Comparator: placebo
matching placebo for linagliptin dose once daily
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01792518
Show 74 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792518
Show 74 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01792518 History of Changes |
| Other Study ID Numbers: |
1218.89 2012-002603-17 ( EudraCT Number: EudraCT ) |
| Study First Received: | February 14, 2013 |
| Results First Received: | November 8, 2016 |
| Last Updated: | January 13, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Kidney Diseases Albuminuria Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Urologic Diseases Proteinuria Urination Disorders Urological Manifestations Signs and Symptoms |
Linagliptin Angiotensin Receptor Antagonists Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 17, 2017