Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Katholisches Klinikum Bochum gGmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

25 Jun 2024 → 7 May 2026

Decision date (initial)

2024-03-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509217-37-00

WHO UTN

U1111-1287-0455

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic

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.

Secondary objectives 2

1. To identify the impact of different post-meal glucose profiles on markers of oxidative stress (Reactive Oxygen Species, ROS) and postprandial triglyceride levels
2. To explore correlations between the subjects’ historical (e.g., diabetes duration, quality of metabolic control), clinical (e.g., presence of neuropathy), and serological (e.g., HbA1c, thyroid parameters) characteristics.

Conditions and MedDRA coding

Type 1 Diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Diabetes mellitus type 1
2. HbA1c ≥ 6.0% [42 mmol/l] and ≤ 8.0% [64 mmol/l]
3. Generally good overall health
4. Age ≥ 18 and ≤ 80 years
5. Body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m²

Exclusion criteria 20

1. Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus
2. Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l])
3. Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization
4. 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)
5. History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy)
6. Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite
7. Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula)
8. Chronic liver disease (transaminases > 2 times the upper normal limit)
9. Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men)
10. Blood donation within the past 12 weeks prior to the study
11. Pregnancy
12. Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment
13. Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day)
14. Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer)
15. Participation in other medical studies within the past three months
16. Inability to provide informed consent
17. Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs)
18. Conventional insulin therapy
19. Proliferative retinopathy
20. Allergies or intolerances that could hinder the study's execution

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is defined as the proportion of participants who achieve the lowest AUC glucose with ultra-rapid-acting insulin analog in the tertiles with the fastest vs. the slowest gastric emptying (t1/2), compared to the proportion of participants who achieve the lowest AUCglucose with regular insulin in the tertiles with the slowest vs. the fastest gastric emptying (t1/2)

Secondary endpoints 5

1. Comparison of meal-associated excursions of ROS (Nitrotyrosine, oxidized Low-Density Lipoproteins (oxLDL))
2. Comparison of meal-associated excursions of plasma glucose and triglyceride concentrations
3. Comparison of gastric emptying rates (t1/2)
4. Coefficient of variation of gastric emptying variability (t1/2)
5. Correlation of AUCglucose with gastric emptying (t1/2) considering the choice of insulin preparation (ultra-rapid-acting insulin, rapid-acting insulin, and regular insulin)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Katholisches Klinikum Bochum gGmbH

Sponsor organisation

Katholisches Klinikum Bochum gGmbH

Address

Gudrunstrasse 56, Grumme Grumme

City

Bochum

Postcode

44791

Country

Germany

Scientific contact point

Organisation

Katholisches Klinikum Bochum gGmbH

Contact name

Medizinische Klinik I

Public contact point

Organisation

Katholisches Klinikum Bochum gGmbH

Contact name

Medizinische Klinik I

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications