The relation between blood glucose control and the number of insulin-producing cells in the body

Beta cell imaging in type 1 diabetes with stable near-normal and unstable glucose control using PET - GLP1-reg

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002739-40-NL

Enrollment

Registered

2017-07-24

Start date

2017-07-27

Completion date

Unknown

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Byetta Product Name: 68Ga-NODAGA-[K40]-Exendin-4 Pharmaceutical Form: Radiopharmaceutical precursor, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: lnclusion criteria: T1D patients with stable near-normal glucose control: - Age =18 years - T1D diagnosed =1 year at the start of the study - HbA1c 8.5 (>69 mmol/mol) - 17= BMI =30 kg/m^2 - Minimum of 2 severe hypoglycemic events in the past year or an impaired awareness of hypoglycemia (IHA), as assessed by a score of 3 or more on the modified Clarke's questionnaire (subjects may comply with both criteria, but this is not a requirement) - Ability to sign informed consent 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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase lV inhibitors - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range - Renal disease defined as MDRD 30 kg/m^2 - Age <18 years - lnability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The main study objective is to measure residual beta cell mass, indicated by the pancreatic uptake of 68Ga-exendin using quantitative PET, in T1D patients with stable near-normal and unstable glucose control, to improve understanding of the relation between residual beta cell mass and glycemic control.;Secondary Objective: The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test. ;Primary end point(s): The main study objective is to determine residual beta cell mass in T1D patients with stable near-normal and unstable glucose control, as determined by measuring pancreatic uptake of Ga-68-exendin-4, to gain a better understanding of the relation between residual beta cell mass and glycemic control.;Timepoint(s) of evaluation of this end point: 1 hour after the administration of the tracer	—

Measure

Time frame

Main Objective: The main study objective is to measure residual beta cell mass, indicated by the pancreatic uptake of 68Ga-exendin using quantitative PET, in T1D patients with stable near-normal and unstable glucose control, to improve understanding of the relation between residual beta cell mass and glycemic control.;Secondary Objective: The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test. ;Primary end point(s): The main study objective is to determine residual beta cell mass in T1D patients with stable near-normal and unstable glucose control, as determined by measuring pancreatic uptake of Ga-68-exendin-4, to gain a better understanding of the relation between residual beta cell mass and glycemic control.;Timepoint(s) of evaluation of this end point: 1 hour after the administration of the tracer

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary aim is to correlate the measured residual beta cell mass to the beta cell function that will be determined by a mixed-meal tolerance test.;Timepoint(s) of evaluation of this end point: After the analysis of the mixed-meal tolerance test and PET/CT scan	—

Countries

Netherlands

Contacts

Public ContactDepartment of Nuclear Medicine

Radboud university medical center

tom.jp.jansen@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026