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

NCT ID: NCT04262661

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-09-25

Brief 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.

Conditions

Healthy Volunteers; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNC0472-0147 Part 1

Part 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.

Group Type: EXPERIMENTAL

NNC0472-0147

Intervention Type: DRUG

Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.

Placebo Part 1

Part 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo (NNC0472-0147)

Intervention Type: DRUG

Part 1: A single dose of placebo, dose increased in each cohort.

NNC0472-0147 Part 2

Part 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days

Group Type: EXPERIMENTAL

NNC0472-0147

Intervention Type: DRUG

Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.

Insulin glargine Part 2

Part 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.

Interventions

NNC0472-0147

Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.

Intervention Type: DRUG

insulin glargine

Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.

Intervention Type: DRUG

Placebo (NNC0472-0147)

Part 1: A single dose of placebo, dose increased in each cohort.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor & Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Mainz, , Germany

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

U1111-1232-3957

Identifier Type: OTHER

Identifier Source: secondary_id

2019-001927-11

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1147-4527

Identifier Type: -

Identifier Source: org_study_id