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Effect of LIXIsenatide on the Renal System (ELIXIRS)

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ClinicalTrials.gov Identifier: NCT02276196
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
M.H.H. Kramer, VU University Medical Center

Study Description
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Brief Summary:

Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes.

Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1 receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes.

Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.


Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Diabetic Nephropathy Diabetes Mellitus Glucagon-Like Peptide 1 Drug: Lixisenatide Drug: Insulin glulisine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Mono-center, Randomized, Open Label, Comparator-controlled, Parallel-group, Mechanistic Intervention Trial to Assess the Effect of 8-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide Versus Insulin Glulisine on Renal Physiology and Biomarkers in Insulin Glargine-treated Patients With Type 2 Diabetes Mellitus
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lixisenatide
Lixisenatide will be administered subcutaneously, once daily for 8 weeks
 Drug: Lixisenatide
GLP-1 receptor agonist
Other Name: Lyxumia
Active Comparator: Insulin glulisine
Insulin glulisine will be administered subcutaneously, once daily for 8 weeks
 Drug: Insulin glulisine
Insulin analogue
Other Name: Apidra


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline following 8-week treatment with a glucagon-like peptide(GLP)-1 receptor agonist versus insulin glulisine on renal hemodynamics, measured as glomerular filtration rate (GFR) / effective renal plasma flow (ERPF) [ Time Frame: 8 weeks ]
    ml/min


Secondary Outcome Measures :
  1. Renal damage, measured by urine biomarkers [ Time Frame: 8 weeks ]
    enzyme immuno assay

  2. Renal tubular function [ Time Frame: 8 weeks ]
    e.g. percentage (%)

  3. Blood Pressure [ Time Frame: 8 weeks ]
    mmHg


Other Outcome Measures:
  1. Body anthropometrics: body weight, height, body mass index, waist circumference [ Time Frame: 8 weeks ]
    kilogram, meters, centimeters

  2. Body fat content [ Time Frame: 8 weeks ]
    e.g. percentage (%)

  3. Glycemic variables [ Time Frame: 8 weeks ]
    e.g. mmol/l, mmol/mol

  4. Lipid spectrum [ Time Frame: 8 weeks ]
    e.g. mmol/l

  5. Inflammatory markers [ Time Frame: 8 weeks ]
    e.g. nmol/l

  6. Systemic hemodynamic variables [ Time Frame: 8 weeks ]
    e.g. ml/min

  7. Heart rate [ Time Frame: 8 weeks ]
    beat per minute

  8. Microvascular function [ Time Frame: 8 weeks ]
    e.g. count

  9. Arterial stiffness [ Time Frame: 8 weeks ]
    e.g. augmentation index


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes (HbA1c: 6.5-10.0% or 48-86 mmol/mol)
  • Stable treatment with basal insulin glargine (dose ±20%) and metformin or basal insulin glargine (dose ±20%) alone for at least 3 months
  • Fasting plasma glucose <10 mmol/L or the use of >50 units of basal insulin glargine
  • Females must be post-menopausal
  • Caucasian
  • Age: 35 - 75 years
  • Body Mass Index: >25 kg/m2
  • Hypertension should be under control, i.e. <140/90 mmHg, and treated with an angiotensin-converting enzyme inhibitor or angiotensin-II-receptor blocker for at least 3 months.
  • Albuminuria should be treated with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin-II-receptor blocker (ARB) for at least 3 months.

Exclusion Criteria:

  • Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, dipeptidyl peptidase (DPP)-4 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants and monoamine oxidase inhibitors. Subjects on diuretics, will only be excluded when these drugs cannot be stopped for the duration of the study.
  • Chronic use of non-steroidal anti-inflammatory drugs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
  • Hypoglycemia unawareness based on investigator judgment
  • History of severe hypoglycemia that required emergency hospital treatment within 3 months prior to screening
  • Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
  • Pregnancy
  • Current urinary tract infection and active nephritis
  • Recent (<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke or transient ischemic neurologic disorder
  • Complaints compatible with or established gastroparesis, neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
  • Active liver disease or a 3-fold elevation of liver enzymes (aspartate aminotransferase/alanine aminotransferase) at screening
  • History of or actual pancreatic disease
  • History of or actual malignancy (except basal cell carcinoma)
  • History of or actual severe mental disease
  • Substance abuse (alcohol: defined as >4 units/day)
  • Allergy to any of the agents used in the study
  • Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
  • Inability to understand the study protocol or give informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276196


Locations
Netherlands
VU Universtiy Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.H.H. Kramer, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02276196     History of Changes
Other Study ID Numbers: DC2014ELIX001
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Insulin, Globin Zinc
 Lixisenatide
Insulin glulisine
Insulin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists