patients with long-standing type 1 diabetes MedDRA version: 14.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism an
Conditions
Interventions
Trade Name: Byetta
Product Name: 111-In-DTPA-[K40]-Exendin4
Pharmaceutical Form: Radiopharmaceutical precursor, solution
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 21-60 years of age • Long-standing T1D (>5 years) or healthy volunteer with normal glucose tolerance • Body mass index (BMI) of 21-27 • No previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors • No measurable C-peptide in T1D patients (stimulated) • Normal HbA1c (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age 60 years • T1D duration 27 • Previous treatment with Exenatide or Dipeptidyl-Peptidase IV inhibitors • Measurable C-peptide in T1D patients • Elevated HbA1c values (>7%) in healthy volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are: • To determine the difference in uptake between the two groups in order to estimate the minimum difference in beta-cell mass (>15%) that would be measurable by GRS. (The beta cell mass in healthy subjects may vary considerably (circa 1-8% of the total pancreatic mass (Ritzel et al 2006)), so that it cannot be predicted what the difference in pancreatic uptake of 111In-DTPA-Exendin between healthy volunteers and patients with long standing T1D will be.) • To perform dosimetric calculations in order determine the effective dose to the patient for EX-scanning and to determine the dose to the individual islets. ;Primary end point(s): Determination of the difference in uptake of the radiotracer into the pancreas between healthy volunteers and patinets with type 1 diabetes.;Timepoint(s) of evaluation of this end point: 4h, 24h, 48h, 96h, 168h;Main Objective: The primary objective is to proof that the pancreatic uptake of EX in patients with long-standing DM1 and non-measurable production of C-peptide, i.e. patients with no relevant beta-cell mass left, is clearly lower than in healthy individuals with intact glucose homeostasis and insulin production. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determination of the minimal difference in beta cell mass that can be measured via the uptake of the radiotracer into the pancreas;Timepoint(s) of evaluation of this end point: 4h, 24h, 48h, 96h, 168h | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Nuclear Medicine
Radboud University Nijmegen Medical Centre
Outcome results
None listed