Status:
COMPLETED
Effect of LIXIsenatide on the Renal System
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Diabetic Kidney Disease
Diabetic Nephropathy
Eligibility:
All Genders
35-75 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02276196
Start Date
September 1 2014
End Date
April 1 2016
Last Update
April 29 2016
Active Locations (1)
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1
VU Universtiy Medical Center
Amsterdam, Netherlands, 1081 HV