Safety and Tolerability of NN9068 in Healthy Male Volunteers

Sponsor
Novo Nordisk A/S
Study ID
NCT00983021
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • insulin degludec/liraglutide — DRUG
    Single, simultaneous dose of NN9068, injected s.c. (under the skin)
  • insulin degludec — DRUG
    Single, simultaneous dose of NN1250, injected s.c. (under the skin)
  • liraglutide — DRUG
    Single, simultaneous dose of NN2211, injected s.c. (under the skin)
  • placebo — DRUG
    Single, simultaneous dose of placebo, injected s.c. (under the skin)

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Feb 2017
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B
  • Active Comparator: C
  • Experimental: D

Primary Outcome Measure

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 ]

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