A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes

  • STATUS
    Recruiting
  • participants needed
    68
  • sponsor
    Novo Nordisk A/S
Updated on 19 February 2024
insulin
diabetes
hysterectomy
oophorectomy
type 2 diabetes mellitus
cholesterol level
bilateral oophorectomy
low density lipoprotein
type 1 diabetes mellitus
bilateral salpingectomy

Summary

This study is investigating the safety and tolerability of the new medicine NNC0472-0147, its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. Another goal of the study is to determine an effect of NNC0472-0147 on cholesterol. The first part of the study is conducted in healthy people, while the second part involves people with type 2 diabetes (T2DM). The study will test how NNC0472-0147 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much blood sugar is lowered. In part 1, participants will either get the new medicine NNC0472-0147 or placebo (an injection that does not contain active medicine) - which treatment is decided by chance. In part 2, participants will either get the new medicine NNC0472-0147 or insulin glargine - which treatment is decided by chance. It is the first time that NNC0472-0147 is tested in humans. Participants will get once daily injections of either NNC0472-0147 or insulin glargine for a treatment period of fourteen days. The injections will be given under the skin (subcutaneously, s.c.) of the left thigh. Participants will be in the study for about 7 weeks. There will be 15 visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health. Only women who cannot become pregnant are allowed to participate.

Details
Condition NIDDM, Healthy Volunteers
Age 18years - 64years
Treatment NNC0472-0147, insulin glargine, Placebo (NNC0472-0147)
Clinical Study IdentifierNCT04262661
SponsorNovo Nordisk A/S
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Part 1
Male
Aged 18-55 years (both inclusive) at the time of signing nformed consent
Part 2
Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (no menses for 12 months without an alternative medical cause) prior to the day of screening
Aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with T2DM at least 180 days prior to the day of screening
Treated with any insulin for 90 days or longer prior to the day of screening
Low-density lipoprotein cholesterol level above 1.80 mmol L

Exclusion Criteria

Part 1
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial
Part 2
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial
Use of oral antidiabetic drugs (OADs) other than metformin or use of glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 90 days prior to the day of screening
Treatment with peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 180 days prior to the day of screening
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