Status:
TERMINATED
Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes
Lead Sponsor:
University of Southern Denmark
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Type 2 diabetes is a major public health concern. It is widely established that type 2 diabetes in linked to activated innate immunity and increased levels of C-reactive protein and interleukin-6 (IL-...
Eligibility Criteria
Inclusion
- Type 2 diabetes, not treated metformin.
- Hemoglobin 1Ac (HbA1c): ≥48 mmol/mol
- Age: 18-75 years
- Body Mass Index (BMI) ≤ 40 kg/m2
- Estimated Glomerular Filtration Rate (eGFR) \> 60 mL/min
- Alanine Aminotransferase (ALAT), bilirubin and hemoglobin within reference range or clinically insignificant differ from this.
Exclusion
- Acute or chronic infection or inflammation
- Active cancer
- Glutamic acid decarboxylase (GAD)-antibodies
- Known hypersensitivity to one or several of the drugs
- Intake of medications which can influence the safety of the patient or the results of the study
- Alcohol consumption above the limits recommended by the Danish Health Authorities (Men 14 units/week, women 7 units/week)
- Participation in other trials with interventions.
- Women: Positive pregnancy test at inclusion or on one of the test-days.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04504045
Start Date
September 1 2020
End Date
May 10 2022
Last Update
June 16 2022
Active Locations (1)
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1
University of Southern Denmark
Odense, Region Syddanmark, Denmark, 5000