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

Drug: Dapansutrile;Drug: Placebo

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 by pill count
during the 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