E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gestational diabetes |
zwangerschapsdiabetes |
|
E.1.1.1 | Medical condition in easily understood language |
Pregnancy Diabetes |
zwangerschapsdiabetes |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018209 |
E.1.2 | Term | Gestational diabetes |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of patients with and without a history of gestational diabetes by quantitative analysis of PET images. |
Het primaire doel is het evalueren van het verschil in 68Ga-exendin tracer opname in de pancreas van patienten met en zonder een geschiedenis van zwangerschapsdiabetes door middel van kwantitatieve analyse van PET beelden. |
|
E.2.2 | Secondary objectives of the trial |
To determine the correlation between 68Ga-exendin tracer accumulation and beta cell function of the subjects as assessed by oral glucose tolerance testing |
Het bepalen van de correlatie tussen 68Ga-exendin tracer opname en beta cel functie van de proefpersonen bepaald door middel van orale glucose-tolerantietest |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria (women with history of GDM)
- Pregnancy with diagnosis of GDM, within the last 5 years
- No other previous pregnancies
- Complete resolution of GDM after delivery (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy or ongoing procedures)
- Signed informed consent
Inclusion criteria (women without history of GDM)
- Pregnancy without problems in glucose homeostasis, within the last 5 years
- No other previous pregnancies
- No evidence of T2D at time of inclusion (HbA1c in normal range, fasting glucose < 100 mg/dl for at least 1 year in the absence of active pharmacologic therapy)
- Insulin secretion-sensitivity index-2 (ISSI-2) ≥ 800 on oral glucose tolerance test
- Signed informed consent
|
Inclusiecriteria (vrouwen met een geschiedenis van zwangerschapsdiabetes)
- Zwangerschap met een diagnose van zwangerschapsdiabetes binnen de afgelopen 5 jaar
- Geen eerdere zwangerschappen
- Complete resolutie van zwangerschapsdiabetes na de bevalling
- getekend toestemmingsformulier
Inclusiecriteria (vrouwen zonder een geschiedenis van zwangerschapsdiabetes)
- zwangerschap zonder problemen met glucose-homeostase in de afgelopen 5 jaar
- geen andere eerdere zwangerschappen
- Geen bewijs voor type 2 diabetes op het tijdstip van inclusie
- Insuline-secretie-sensitiviteits index-2 (ISSI-2) > 800 op oral glucose-tolerantietest
- getekend toestemmingsformulier |
|
E.4 | Principal exclusion criteria |
Exclusion criteria
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Breast feeding
- Current pregnancy or the wish to become pregnant within 6 months
- Renal dysfunction (Calculated creatinine clearance below 40ml/min)
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
- Age < 18 years
- Incapacitated
- No signed informed consent
|
Exclusiecriteria:
- eerder behandelijk met synthetisch exendin
- borstvoeding
- huidige zwangerschap of de wens om binnen 6 maanden zwanger te worden
- Nierfunctiestoornissen
- Leverfunctiestoornissen
- leeftijd < 18 jaar
- gehandicapt
- geen getekende toestemming |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The main parameter of the study is the quantitative assessment of pancreatic 68Ga-NODAGA-exendin-4 uptake women with and without a history of GDM by PET/CT. |
De kwantitatieve analyse van opname van 68Ga-exendin-4 in de pancreas van vrouwen met en zonder zwangerschapsdiabetes |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after injection of the tracer |
1 uur na injectie van de tracer |
|
E.5.2 | Secondary end point(s) |
The correlation between Ga-exendin tracer accumulation and beta cell function of the subjects |
De correlatie tussen Ga-exendin tracer opname en de beta cel functie van de deelnemers |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 hour after injection of the tracer |
1 uur na injectie van de tracer |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |