Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT01686945
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
  • semaglutide — DRUG
    Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
  • semaglutide — DRUG
    Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
  • placebo — DRUG
    Placebo semaglutide. For oral administration.
  • placebo — DRUG
    Placebo semaglutide with carrier. For oral administration.

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long-acting GLP-1 analogue (oral semaglutide) and a carrier in healthy male subjects and male subjects with type 2 diabetes (T2D).

Key Dates

Start date
Sep 19, 2012
Status verified
Jan 2019
Primary completion
Apr 8, 2013
Completion
Apr 8, 2013

Study Design

Enrollment
107 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy - 20 mg
  • Experimental: Healthy - 40 mg
  • Experimental: Healthy - 60 mg
  • Experimental: T2D - 20/40/60 mg

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104) ]

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