Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes. The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
Interventions
DRUGNN1952
Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
DRUGinsulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
DRUGplacebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* FOR TRIAL PART 1, THE FOLLOWING APPLIES: * Gender: male * Age: 18-55 years * BMI (body mass index): 18-28 kg/m2 * Study participants considered to be healthy * FOR TRIAL PART 2, THE FOLLOWING APPLIES: * Gender: male or female of no childbearing potential * Age: 18-65 years * Type 1 diabetes: BMI (body mass index): 18-28 kg/m2 * Type 2 diabetes: BMI (body mass index): 22-35 kg/m2 * Type 1 or type 2 diabetes for at least 12 months * Type 1 diabetes: Treatment with insulin for at least 12 months * Type 2 diabetes: Treatment with insulin for at least 3 months
Exclusion criteria
* Known or suspected allergy to the trial product or related products * Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator * Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and severity of adverse events for trial part 1 | from visit 1 to visit 3 |
| Number and severity of adverse events for trial part 2 | from visit 1 to visit 6 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve after a single dose | after 12 hours |
| Area under the glucose infusion rate-time curve after a single dose | after 12 hours |
Countries
Germany
Outcome results
None listed