A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes
NCT04582448 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2023-01-20
Summary
This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Insulin icodec
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2021-09-27
- Completion
- 2021-09-27
Countries
- Germany
Study Locations
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