NCT00983021
Completed
Phase 1
A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- insulin degludec/liraglutide
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.
The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
- •Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
- •Body weight between 60 kg and 90 kg (both inclusive)
Exclusion Criteria
- •Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator
Arms & Interventions
A
Intervention: insulin degludec/liraglutide
A
Intervention: placebo
B
Intervention: insulin degludec
B
Intervention: placebo
C
Intervention: liraglutide
C
Intervention: placebo
D
Intervention: insulin degludec
D
Intervention: liraglutide
Outcomes
Primary Outcomes
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
Time Frame: assessed 0-96 hours after trial product administration
Secondary Outcomes
- The area under the NN2211 concentration-time curve after single-dose(assessed 0-72 hours after trial product administration)
- The area under the NN1250 concentration-time curve after single-dose(assessed 0-96 hours after trial product administration)
Study Sites (1)
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