Diabetes
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Able and willing to provide written informed consent - Age 18 to 65 years - Males or females
Exclusion criteria
Exclusion criteria: - Clinically significant abnormalities in medical history, physical examination or laboratory examination - Pregnanant or breast feeding females - Not able or willing to use an acceptable contraceptive method for study duration for females (hormonal contraceptives, intra-uterine device or condom/pessary) - Not able and willing to refrain from smoking and/or xanthine use on study day - Fasting plasma glucose at screening >= 6.4 - HbA1C >= 7% - BMI >= 30 kg/m2 - Hypertension (systolic blood pressure >= 140 mm Hg or a diastolic blood pressure >= 95 mm Hg) - Suspicion of a pheochromocytoma (i.e. Rapid heart rate, palpitations, excessive sweating, chest pain, upper abdominal pain, severe headaches, tremors, feeling of anxiety or extreme fright, pale skin) - Positive urine testing for cocaine, opiates (morphine) and/or THC at screening - Use of concomitant medication (except hormonal contraceptives) - Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus - History of alcohol or drug abuse - Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening. - Blood donation within three months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentrations of (labelled)glucose, glucagon, insulin, C-peptide, GH and active GLP1, glucose levels with a continuous glucose monitoring device, calculation of hepatic glucose production and expression of glucagon receptor mRNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of biopsies, glucose monitoring and glucagon challenge | — |
Countries
Netherlands
Outcome results
None listed