Type 2 diabetes mellitus on stable oral anti-diabetic treatment
Conditions
Interventions
Group 1: Aescuven®, coated tablets (containing 105.0-141.0 mg horse chestnut seed extract, standardized to 12.5 mg triterpenglycosides, calculated as protoaescigenin per tablet). Intake 2x 2 tablets (
Intake 2x 2 tablets over 4 weeks.
Sponsors
Cesra Arzneimittel GmbH & Co.KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Subjects of any sex (at least 25% men or women) • Willing to provide personally written informed consent • At least 18 years of age at time of consent • Willing and able to understand the nature, significance and consequences of the clinical trial • have type 2 diabetes with stable anti-diabetic treatment (no change in dose or composition over the last three months) • have a stable treatment for all concomitant diseases (no change in dose or composition over the last three months)
Exclusion criteria
Exclusion criteria: • Body Mass Index (BMI) >35 kg/m² • HbA1C >7.5% • Subjects who have participated in an interventional clinical research study within the previous 3 months. • Subjects who are taking bolus-insulin or sulfonylurea drugs as anti-diabetic medication or PII treatment within the previous 3 months. • Subjects with regular or occasional intake of herbal vasoactive drugs (e.g. HCSE, Ginkgo, Ginseng, red wine leaves, diosmin/hesperidin) • Subjects with occasional intake of vasodilating drugs (Nitrates, ACE-inhibitors, alpha-blockers, phosphodiesterase inhibitors, Ca-antagonists, Minoxidil, Dihydralazin, Dihydroergotoxin, Pentoxifylin) or acetylsalicylic acid > 100 mg/d • Subjects with occasional intake of vasoconstrictors (caffeine tablets, amphetamine, alpha-1-agonists, dopamine, ephedrine, norephedrine) • Manifest neuropathy • Smokers • Pregnant or breast-feeding women • Severe disease with expected life expectancy less than 2 years or at the investigator’s discretion • Study site employees, or immediate family members of a study site or sponsor employee. • Subjects with symptomatic malabsorption disorders (Crohn’s Disease, Colitis ulcerosa, lactose or gluten intolerance) • Subjects with rheumatoid disorders • Weight loss intervention or recent body weight change greater than 5 kg during last 3 months • Known allergy to any component of the investigational product • Blood donation within 4 weeks prior to Visit 1 or during the study • Anticipating any planned changes in lifestyle and nutrition habits for the duration of the study • Clinical or laboratory evidence of hepatic or renal dysfunction or disease at investigator’s discretion; laboratory evidence defined as any of the following parameters: ALAT, ASAT >3x ULN; eGFR < 30 mg/min/1.73 m2 • Subjects who have previously been enrolled in this study. • Any subject who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures (e.g., cognitive impairment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment induced changes from corresponding Baseline visit (visit 1 and visit 3) in the maximal microvascular blood flow after post-ischaemic reactive hyperaemia response (PRH) (arm), evaluated by the laser Doppler flowmeter (O2C) at 2 mm after 4 weeks of treatment with either verum or placebo (visit 2 and visit 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Treatment induced changes from corresponding baseline visit (visit 1 and visit 3) in the maximal microvascular blood flow after post-ischaemic reactive hyperaemia response (PRH) (arm), evaluated by the laser Doppler flowmeter (O2C) at 8 mm after 4 weeks of treatment (visit 2 and visit 4) with either verum or placebo). • Treatment induced changes from corresponding baseline visit (visit 1 and visit 3) in the basal laser doppler flowmetry (bLDF) at 2 mm and 8 mm, evaluated by the laser Doppler flowmeter (O2C) after 4 weeks of treatment (visit 2 and visit 4) with either verum or placebo. • Treatment induced changes from corresponding baseline visit (visit 1 and visit 3) of further parameters of microcirculation evaluated by the laser Doppler flowmeter (O2C) (oxygen saturation (SO2) and relative amount of haemoglobin (rHb)) after 4 weeks of treatment (visit 2 and visit 4) with either verum or placebo. • Treatment induced changes from corresponding baseline visit (visit 1 and visit 3) in the laser doppler flowmetry (LDF), evaluated by the laser Doppler flowmeter (O2C) during Pulsatile Insulin Infusion (PII) Challenge, with measurements at baseline, 30, 60, 90, and 120 minutes (leg) after 4 weeks of treatment (visit 2 and visit 4) with either verum or placebo. • Treatment induced changes from corresponding baseline visit (visit 1 and visit 3) of adiponectin, hsCRP, insulin and intact proinsulin concentrations after 4 weeks of treatment (visit 2 and visit 4) with either verum or placebo (optionally). Additional endpoint parameters: • Change in Glucose infusion rates during Pulsatile Insulin Infusion procedure with either verum or placebo. • Evolution of nitrotyrosine and asymmetric dimethylarginine (ADMA) (optional analysis) during Pulsatile Insulin Infusion procedure with either verum or placebo. | — |
Countries
Germany
Contacts
Public ContactAndreas Pfützner
PSHI Praxis GmbH
Outcome results
None listed