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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05854251
Other study ID # 2023-00497; kt23Donath2
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 15, 2023
Est. completion date May 2024

Study information

Verified date July 2023
Source University Hospital, Basel, Switzerland
Contact Marc Donath, Prof.
Phone +41 61 265 25 25
Email marc.donath@usb.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l. - BMI = 28 kg/m2 - Age = 18 years - C-reactive protein = 2 mg/dl - For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study Exclusion Criteria: - Upper gastrointestinal surgery - Diagnosis of any type of diabetes mellitus - Signs of current infection - Use of any glucose lowering medication within the last three months - Use of investigational drug up to one week prior to start of treatment phase. - Anti-inflammatory medication, including systemic glucocorticoid therapy. - Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L) - Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females) - Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN) - Uncontrolled disease - Currently pregnant or breastfeeding - No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study

Study Design


Intervention

Drug:
Anakinra
Subjects receive an s.c. injection of 100 mg Anakinra on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal
Placebo
0.67 ml of s.c. injection of saline will be taken on the evening before and on the respective study day 60 minutes before ingestion of the mixed-meal

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in insulin concentration following a standardized mixed-meal test Changes in insulin concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. two time assessment at baseline and after 1-2 weeks
Primary Change in glucose concentration following a standardized mixed-meal test Changes in glucose concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. two time assessment at baseline and after 1-2 weeks
Primary Change in c-peptide concentration following a standardized mixed-meal test Changes in c-peptide concentration (nmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal. two time assessment at baseline and after 1-2 weeks
Primary Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test Changes in insulinogenic index (IGI) (I30 - I0)/(G30 - G0) under anakinra compared to placebo.
Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
two time assessment at baseline and after 1-2 weeks
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