A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT04007107
Phase
PHASE2
Status
Completed

Conditions

  • Healthy Volunteers Diabetes Mellitus, Type 2
  • Healthy Volunteers Obesity
  • Healthy Volunteers Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study in healthy men and women compares the injection site experience of the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (sc, under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.

Key Dates

Start date
Jun 27, 2019
Status verified
Jul 2020
Primary completion
Jul 28, 2019
Completion
Sep 4, 2019

Study Design

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

Arms

  • Experimental: DV3396 followed by PDS290
    The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach
  • Experimental: PDS290 followed by DV3396
    The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach

Primary Outcome Measure

Intensity of Injection Site Pain [ Time Frame: After 1 minute of each injection (Day 1) ]