2023-509217-37-00CompletedPhase 1
Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes
Influence of various fast-acting mealtime insulin preparations in individuals with type 1 diabetes, with slow, moderate, and rapid gastric emptying, on postprandial blood glucose and the formation of reactive oxygen species
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Sept 2025
Brief summary (registry, in English)
The primary objective of the study is to optimize postprandial blood glucose profiles (avoiding excessive hyperglycemia and its consequences on accompanying oxidative stress reactions) by considering the velocity of gastric emptying through the selection of the most suitable rapid-acting mealtime insulin.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Jan 2024
- Start date
- 25 Jun 2024
- Lead sponsor
- Katholisches Klinikum Bochum gGmbH
- Diseases
- Type 1 diabetes
- EU CT number
- 2023-509217-37-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Blood donation within the past 12 weeks prior to the study
- Conventional insulin therapy
- Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization
- Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite
Other illness
- Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus
- Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer)
- Allergies or intolerances that could hinder the study's execution
- Positive medical history of gastrointestinal diseases, especially symptomatic upper or lower gastrointestinal tract disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease, pancreatitis, gastric conditions like gastroparesis)
- History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy)
Lab values
- Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l])
- Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula)
- Chronic liver disease (transaminases > 2 times the upper normal limit)
- Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men)
Other
- Pregnancy
- Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment
- Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day)
- Participation in other medical studies within the past three months
- Inability to provide informed consent
- Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs)
- Proliferative retinopathy
Who the study is looking for
- Diabetes mellitus type 1
- HbA1c ≥ 6.0% [42 mmol/l] and ≤ 8.0% [64 mmol/l]
- Generally good overall health
- Age ≥ 18 and ≤ 80 years
- Body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m²
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Katholisches Klinikum Bochum gGmbH | Bochum | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.