MARLINA : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01792518
First received: February 14, 2013
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
In a pooled, post-hoc analysis in patients with albuminuria, treated with current standard background therapy for diabetic nephropathy (ACEi or ARB), linagliptin significantly lowered markers of glucose control, such as HbA1c, after 24 weeks of treatment. In addition, UACR was lowered by 29% vs. placebo. Hence the hypothesis was generated that linagliptin may have clinically meaningful glycemic efficacy in this particular patient population and an antialbuminuricbpotential on top of current standard treatment for diabetic nephropathy that isbindependent of its glucose-lowering potentials.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: Linagliptin 5mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 Treatmentwith 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 Pharmaceuticals:
Primary Outcome Measures:
- Change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The time weighted average of percentage change from baseline in UACR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 404 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2014 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus
- Glycosylated Hemoglobin (HbA1c) between 7 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 Sulfonylurea (SU), a glinide, a dopamine-agonist, a bile-acid sequestrant or insulin (except basal 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792518
Show 74 Study Locations
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 74 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01792518 History of Changes |
| Other Study ID Numbers: | 1218.89, 2012-002603-17 |
| Study First Received: | February 14, 2013 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Health Canada Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Agence Nationale sécurité médicament et des produits santé Germany: Federal Institute for Drugs and Medical Devices Japan: Ministry of Health, Labor and Welfare Philippines: Department of Health South Korea: Ministry of Food and Drug Safety (MFDS) Spain: Spanish Agency of Medicines Taiwan : Food and Drug Administration United States: Food and Drug Administration Vietnam: Ministry of Health |
Additional relevant MeSH terms:
|
Albuminuria Diabetes Mellitus Diabetes Mellitus, Type 2 Kidney Diseases Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Angiotensin Receptor Antagonists BI 1356 Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013