Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology

Korábbi kezelés

• Previous participation in this trial. Participation is defined as having completed at least one clamp.
• A positive result in the alcohol and/or urine drug screen at the screening visit.
• Current use of systemic medication that could interfere with the interpretation of the trial endpoints (insulin sensitivity assessment), as judged by the Investigator

Más betegség

• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any serious systemic infectious disease within the last four weeks, as judged by the investigator
• Signs of acute illness as judged by the investigator
• Significant history of alcoholism as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average
• Tested positive for hepatitis Bs antigen
• Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative)
• Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen

Laborértékek

• Clinically significant abnormal screening laboratory tests, as judged by the investigator.

Egyéb

• Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
• Clinically relevant comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data
• Clinically significant abnormal findings for vital signs and ECG recordings, as judged by the investigator
• Daily smoker or using nicotine substitute products
• Blood donation or blood loss of more than 500 mL within the last 3 months
• If female, pregnancy or breast-feeding

• Signed and dated informed consent has been obtained
• Participant is male or female
• Age between 18 and 65 years, both inclusive
• Obese people or people diagnosed with type 2 diabetes
• BMI, \> 30 kg/m2, for obese participants and people with type 2 diabetes
• Has venous access sufficient to allow cannulation for blood sampling as required by the protocol