Status:
COMPLETED
Impact of Hypoglycaemia in Patients With Diabetes Mellitus Type 2 on Platelet Activation
Lead Sponsor:
Medical University of Graz
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Diabetes Mellitus With Hypoglycemia
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This experimental study is planned to investigate the impact of hypoglycaemia on platelet activation parameters (PAP) during a hyperinsulinaemic hypoglycaemic clamp study. The hypothesis that hypoglyc...
Detailed Description
Increased platelet activation is significantly involved in the pathophysiology of micro- and macrovascular diabetic complications. Previously performed studies suggested platelet activation in both, h...
Eligibility Criteria
Inclusion
- Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
- Subjects diagnosed with type 2 diabetes (diagnosed regarding world health organization \[WHO\] criteria) and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy or diet only. Stable is defined as unchanged dose
- Body mass index (BMI) between 20.0 and 35.0 kg/m2 (both inclusive)
- HbA1c between 43 and 64 mmol/mol (6.0% - 8.0%) (both inclusive)
- No use of platelet inhibiting therapy (e.g. aspirin, clopidogrel, ticagrelor, prasugrel)
Exclusion
- All other forms of diabetes (type 1 diabetes, gestational diabetes) than type 2 diabetes mellitus
- Treatment with any glucose lowering agent(s) other than metformin in a period of 60 days before screening. An exception is short-term treatment (≤ 7 days in total) with insulin due to intercurrent illness
- Impaired hypoglycaemic awareness determined at the discretion of the investigator
- Medical history of arrhythmia as atrial fibrillation, atrial flutter, atrioventricular dissociation disorders or ventricular arrhythmias
- Previously known cardiovascular disease and / or past cardiovascular events, or past episodes of a congestive heart failure syndrome (NYHA II - NYHA IV)
- Severe hypoglycaemic event requiring third party help in the last 6 months
- Known allergy to human insulin or dextrose solution
- Clinically significant abnormal haematology, biochemistry, lipids, hormones, coagulation or urinalysis
- Uncontrolled hypertension defined as resting blood pressure at screening (after resting for 5 min, measured in sitting position) outside the range of 90-160 mmHg for systolic or 50-100 mmHg for diastolic
- Chronic liver failure with severe liver dysfunction as assessed by the investigator
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) levels \> 3x upper Limit of normal (ULN)
- estimated Glomerular Filtration Rate (eGFR) \<45 ml/min/1,73 m2
- Any musculoskeletal disorders holding back from stay in bed in a lying position during the time of the clamp experiments
- Treatment with beta-blockers, antiarrhythmic agents or neuroleptic drugs
- Active smoker or intake of illicit substances
- Regular intake of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Any mental disorders or psychiatric conditions which may interfere with understanding or conduction of study related procedures
- Females of child bearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectomised partner; or medical history of hysterectomy)
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03460899
Start Date
February 12 2018
End Date
June 11 2018
Last Update
November 18 2019
Active Locations (1)
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1
Medical University of Graz, Department for Internal Medicine
Graz, Austria, 8036