Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutide
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of admini
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Both genders -Age between 35 and 70 years. Females must be post-menopausal (no menses >1 year). -Type 2 diabetes (HbA1c 6.5-9% DCCT or 48-75 mmol/mol IFCC), who are being treated with a stable dose of oral antihyperglycemic agents (either metformin alone, SU alone or a combination of metformin and SU) for at least 3 months prior to inclusion. -BMI 25 - 40 kg/m2 - Caucasian For the preceding pilot-study: - Males - Age between 18 and 50 years - BMI 25 – 40 kg/m2 - Caucasian Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - GFR 4 units alcohol/day (because of risk of pancreatitis) - History of allergy/hypersensitivity to GLP-1RA, DPP-4i, inulin, para-aminohippuric acid, acetaminophen, secretin, MRI contrast agent or latex (component of PAH). - Complaints compatible with or established gastroparesis and/or neurogenic bladder - Any condition that has been recognized as a contra-indication for the use of GLP-1RA and DPP-4i, as listed in the respective SPCs - History of or actual (severe) mental illness - Inability to understand the study protocol and/or inability to give informed consent - History of claustrophobia or presence of metal objects/implants (because of MRI protocol) For the preceding pilot-study: Similar to the exclusion criteria for the main study, with the additions of: - Subjects with a fasting plasma glucose =5.6 mmol/L, a 2-hour glucose of =7.8 mmol/L after a 75-grams oral glucose tolerance test, or a HbA1c of =6.5% - Subjects using any kind of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cardiovascular part: to assess the acute effects of GLP-1RA and the long-term effects of both GLP-1RA and DPP-4i on resting heart rate variability. Renal part: to assess the acute effects of GLP-1RA and the long-term effects of both GLP-1RA and DPP-4i on glomerular filtration rate. Gastrointestinal part: to assess the long-term effect of GLP-1RA and DPP-4i on fecal elastase-1. ;Secondary Objective: Cardiovascular part: to measure the acute effects of GLP-1RA and the long-term effects of both GLP-1RA and DPP-4i on blood pressure, heart rate, hemodynamic variables, autonomic nervous system (ANS) function, microvascular function, arterial stiffness, plasma lipid spectrum, glycemic variables (all of the fore-mentioned variables will be assessed in the fasting and postprandial state), body anthropometrics and body fat content. Renal part: to measure the acute effects of GLP-1RA and the long-term effects of both GLP-1RA and DPP-4i on renal plasma flow, renal tubular function and renal damage parameters. Gastrointestinal part: to measure the long-term effect of GLP-1RA and DPP-4i on different aspects of pancreatic exocrine function/structure, plasma pancreatic enzymes, gallbladder motility, liver enzymes, hepatic function, hepatic steatosis and gastric emptying speed. ;Primary end point(s): Cardiovascular part: resting heart rate variability Renal part: glomerular filtration rate. Gastrointestinal part: fecal elastase-1. ;Timepoint(s) of evaluation of this end point: All are assessed at baseline and after 12 weeks of treatment. The cardiovascular and renal primary endpoints are also evaluated during an acute infusion experiment at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiovascular part: - Blood pressure - Heart rate - Hemodynamic variables - Autonomic nervous system (ANS) function - Microvascular function - Arterial stiffness - Plasma lipid spectrum - Glycemic variables - Body anthropometrics and body fat content Renal part: - Renal plasma flow - Renal tubular function - Renal damage parameters Gastrointestinal part: - Pancreatic exocrine function/structure - Plasma pancreatic enzymes - Gallbladder motility - Liver enzymes - Hepatic function - Hepatic steatosis - Gastric emptying speed ;Timepoint(s) of evaluation of this end point: All are assessed at baseline and after 12 weeks of treatment. The cardiovascular and renal primary endpoints are also evaluated during an acute infusion experiment at baseline. | — |
Countries
Netherlands
Contacts
Public ContactMark Smits
VU University Medical Center
Outcome results
None listed