Type 2 Diabetes Mellitus
Conditions
Interventions
Trade Name: Lyxumia
Product Name: Lixisenatide
Pharmaceutical Form: Solution for injection in pre-filled pen
Trade Name: Lyxumia
Produc
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Type 2 diabetes mellitus •Caucasian •Both genders (females must be post-menopausal; no menses >1 year) •Age: 35 - 75 years •BMI: 25 - 40 kg/m2 •HbA1c: 6.5 - 10% DCCT (48 - 86 mmol/mol International Federation of Clinical Chemistry) •Stable treatment with basal insulin glargine and metformin or basal insulin glargine alone •Fasting plasma glucose (FPG) 50 units of basal insulin glargine •Hypertension should be under control, i.e. =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: •Current/chronic use of the following medication: TZD, SU derivative, GLP-1RA, DPP-4I, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). 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 (NSAIDs) 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 4 units/day) •Allergy to any of the agents used in the study (i.e. GLP-1RA, inulin, metacresol (component lixisenatide and insulin glulisine), PAH, latex (component of PAH vial stopper)) •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To assess the long-term effects (i.e. after 8-week drug exposure) of the GLP-1RA lixisenatide versus insulin glulisine on renal hemodynamics (glomerular filtration rate/effective renal plasma flow) in patients with type 2 diabetes;Secondary Objective: Secondary objectives: renal damage, renal tubular function, blood pressure; Primary end point(s): To assess changes from baseline following 8-week treatment with a GLP-1RA versus a single dose of insulin on renal hemodynamics measured as: •Glomerular filtration rate (measured by the inulin-clearance technique) •Effective renal plasma flow (measured by the para-aminohippurate acid clearance technique) ;Timepoint(s) of evaluation of this end point: Renal hemodynamics are assessed at baseline and after 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary endpoints are assessed at baseline and after 8 weeks of treatment; Secondary end point(s): To assess changes from baseline following 8-week treatment with a GLP-1RA versus a single dose of insulin on: •Renal damage, measured by urine biomarkers as: oUrinary albumin excretion (Glomerular) oNeutrophil gelatinase-associated lipocalin and Kidney injury molecule-1 (Tubular) •Renal tubular function, measured as: oFractional sodium-, potassium-, chloride-, calcium-, magnesium-, phosphate- and urea excretion oUrine osmolality •Systolic blood pressure, diastolic blood pressure and mean arterial pressure (measured by oscillometric blood pressure device) | — |
Countries
Netherlands
Contacts
Public ContactLennart Tonneijck
VU University Medical Center
Outcome results
None listed