A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

Sponsor
Novo Nordisk A/S
Study ID
NCT05435677
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • IcoSema — DRUG
    One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
  • insulin icodec — DRUG
    One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
  • semaglutide — DRUG
    One single dose of semaglutide administered subcutaneously, S.c. into the left thigh

Study Details

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes. IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide. Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan. The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide. Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints: The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Key Dates

Start date
Jun 22, 2022
Status verified
Mar 2025
Primary completion
Apr 25, 2023
Completion
Apr 25, 2023

Study Design

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

Arms

  • Experimental: Sequence 1
    All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
  • Experimental: Sequence 2
    All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
  • Experimental: Sequence 3
    All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
  • Experimental: Sequence 4
    All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
  • Experimental: Sequence 5
    All participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.
  • Experimental: Sequence 6
    All participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.

Primary Outcome Measure

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose [ Time Frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration ]

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