The comparison of the number of insulin-producing cells during and shortly after the honeymoon phase of type 1 diabetes

Comparison of the beta cell mass during and shortly after the honeymoon phase of type 1 diabetes using Ga-68-exendin PET - GLP1-honeymoon

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002959-29-NL

Enrollment

Registered

2017-11-13

Start date

2018-10-15

Completion date

Unknown

Last updated

2025-01-27

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: Inclusion criteria: - Age =16 years - Subject is diagnosed with type 1 diabetes (T1D) - Presence of anti-GAD (glutamic acid decarboxylase) - Subject is in the honeymoon phase of T1D: IDAA1c =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 <16 years - When the end of the honeymoon phase (IDAA1c =9) is not observed within 11 to 13 months after the inclusion of the subject - lnability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine possible differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Secondary Objective: The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.;Primary end point(s): The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine the differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Timepoint(s) of evaluation of this end point: 1 hour after the administration of the tracer (for both scans)	—

Measure

Time frame

Main Objective: The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine possible differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Secondary Objective: The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.;Primary end point(s): The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine the differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Timepoint(s) of evaluation of this end point: 1 hour after the administration of the tracer (for both scans)

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.;Timepoint(s) of evaluation of this end point: After the analysis of the mixed-meal tolerance tests and PET/CT scans	—

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