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SNCTP000005781 | NCT06047262 | BASEC2023-01387

Dapansutril zur Behandlung von Diabetes Typ 2 und damit verbundener Folgeerkrankungen – Dapan-Dia Studie

Data source: BASEC (Imported from 19.04.2024), WHO (Imported from 18.04.2024)
Changed: Jan 24, 2024, 11:20 AM
Disease category: Endocrinological diseases (non cancer)

Brief description of trial (Data source: BASEC)

In dieser Studie wird der Effekt von Dapansutril auf die Blutzuckereinstellung bei Patientinnen und Patienten mit Typ 2 Diabetes mellitus untersucht. Beim Typ 2 Diabetes liegt häufig ein dauerhafte Entzündung im Körper vor, die durch das Immunsystem begünstigt wird und an der Verschlechterung des Diabetes und von Folgeerkrankungen des Diabetes mit verantwortlich gemacht wird. Im Rahmen dieser Studie wird ein neu entwickelter Entzündungshemmer (Dapansutril) des sogenannten NLRP3-Inflammasoms in Tablettenform über 30 Wochen Behandlungszeit hinsichtlich seiner Wirkung auf den Blutzucker und seine Sicherheit getestet. Wir möchten in erster Linie einen günstigen Effekt auf die Blutzuckereinstellung untersuchen und im weiteren auch verstehen, wie sich der Stoffwechsel allgemein, aber insbesondere Immunzellen verhalten sowie den Einfluss auf Folgeerkrankungen vom Diabetes untersuchen.

Health conditions investigated(Data source: BASEC)

Diabetes mellitus Typ 2

Health conditions (Data source: WHO)

Diabetes Mellitus, Type 2

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Langzeit-Blutzucker: HbA1c
Stoffwechselwerte (Blutzucker, Insulin, C-Peptid)
Entzündungswerte
Nierenfunktionsveränderungen (allgemeine Nierenfunktion und Eiweiss-Ausschüttung im Urin)
Nervenfunktion der Hände/Füsse
Netzhautveränderungen

Interventions (Data source: WHO)

Drug: Dapansutrile;Drug: Placebo

Criteria for participation in trial (Data source: BASEC)

Alter von 18-75 Jahren
Typ 2 Diabetes mellitus seit mindestens 3 Monaten
HbA1c (Langzeitblutzucker) zwischen 7.7 und 11.0 %
hsCRP ≥ 1.5 mg/l
BMI (body mass index) 18-40 kg/qm
Bereitschaft an der Studie vollumfänglich teilnehmen zu wollen

Exclusion criteria (Data source: BASEC)

Unkontrollierte Nieren-, Herz- und Lebererkrankung
Infektion
Behandlung mit Medikamenten, die das Immunsystem bremsen/hemmen
Aktive bösartige Erkrankung
Behandlung mit Bolus/Kombinations(Essens)-Insulin oder Glitazone
Blutarmut (Anämie bei Männern unter 120 g/l, bei Frauen unter 110 g/l) oder Erkrankungen der roten Blutkörperchen
Schwangerschaft und Stillzeit

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: 75 Years
Minimum age: 18 Years

Inclusion Criteria:

- Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American
Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of
Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization
(WHO, 2019), for at least 3 months prior to the Baseline Visit/Day 1

- HbA1c value of = 7.7% to = 11.0% at the Screening Visit.

- High-sensitivity C-reactive protein (hsCRP) = 1.5 mg/L at the Screening Visit.

- Body mass index (BMI) =18 to = 40 kg/m2 at the Screening Visit

- Acceptable overall medical condition to safely participate in the study and complete
all study procedures (particularly with regard to cardiovascular, renal, and hepatic
conditions), in the opinion of the Investigator

Exclusion Criteria:

- Diagnosis of type 1 diabetes mellitus

- HbA1c value of = 7.5% or = 10.5% at the Baseline Visit/Day 1, as determined at point
of care (local laboratory)

- Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin
analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit

- Less than 80% compliance in taking investigational medicinal product (placebo tablets)
by pill count during the Single-Blind Run-In Period, as assessed at the Baseline
Visit/Day 1

- Significant weight loss (> 5 kg) in the 12 weeks prior to the Screening Visit

- Systolic blood pressure (BP) = 160 mmHg, diastolic BP = 100 mmHg, or resting heart
rate (HR) = 100 beats/minute at the Screening Visit

- Previous myocardial infarction, any cardiac surgery

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT06047262

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06047262
Further information on trial

Recruitment status

Not yet recruiting

Academic title (Data source: WHO)

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of the Oral NLRP3 Inhibitor Dapansutrile in Subjects With Type 2 Diabetes Mellitus

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Change in HbA1c in blood of patients for dapansutrile compared to placebo

Secundary end point (Data source: WHO)

Change in HbA1c in blood of patients for dapansutrile compared to placebo;Change in fasting plasma glucose for dapansutrile compared to placebo

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof Dr Marc Y Donath
0612652525
marc.donath@usb.ch

Contact for general information (Data source: WHO)

Marc Y. Donath, Prof.
University Hospital, Basel, Switzerland
+41 61 265 50 78;+41 61 265 5078
Marc.Donath@usb.ch;marc.donath@usb.ch

Contact for scientific information (Data source: WHO)

Marc Y. Donath, Prof.
University Hospital, Basel, Switzerland
+41 61 265 50 78;+41 61 265 5078
Marc.Donath@usb.ch;marc.donath@usb.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

24.01.2024

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2023-01387

Secondary ID (Data source: WHO)

kt23Donath
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