Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDefymed
About this trial
First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia
Eligibility criteria
Qualifiers
Adult men or women (age ≥ 18 years);
Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening;
Body mass index (BMI) > 16 kg/m2 and < 35 kg/m2;
CSII, whatever the insulin pump used, and
Disqualifiers
Renal glomerular filtration rate <30 mL/min/1.73m2 as per Chronic Kidney Disease - Epidemiology Collaboration (CDK-EPI) calculation;
Immunocompromised patient;
Local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia);
Active infection or inflammation;
Trial design
Treatments tested in this trial
- ExOlin®
- Insulin aspart
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov