Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
NCT01865318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2015-10-22
Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.
Conditions
- Diabetes
- Diabetes Mellitus, Type 1
Interventions
- DRUG
-
insulin degludec
Administered subcutaneously (s.c., under the skin)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2007-01-31
- Completion
- 2007-01-31
Countries
- Germany
Study Locations
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