Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT01319240
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

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

Interventions

  • insulin degludec — DRUG
    Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
  • insulin degludec/liraglutide — DRUG
    Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
  • liraglutide — DRUG
    Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.

Study Details

This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of insulin degludec and liraglutide, when administered either combined or as separate administrations.

Key Dates

Start date
Mar 31, 2011
Status verified
Oct 2015
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: IDegLira
  • Active Comparator: IDeg
  • Active Comparator: Lira

Primary Outcome Measure

The area under insulin degludec concentration-time curve [ Time Frame: from 0-infinity hours after trial product administration ]

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