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

NCT04262661 | Completed Phase 1

• 3 other identifiers: NN1147-4527U1111-1232-39572019-001927-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Number of treatment emergent adverse events

  Number of events

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

• Part 2: Number of treatment emergent adverse events

  Number of events

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

Secondary Outcomes (10)

• Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

• Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

• Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

• Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

• Number of severe hypoglycaemic episodes (level 3)

  From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

Study Arms (4)

NNC0472-0147 Part 1

EXPERIMENTAL

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.

Drug: NNC0472-0147

Placebo Part 1

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0472-0147)

NNC0472-0147 Part 2

EXPERIMENTAL

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

Drug: NNC0472-0147

Insulin glargine Part 2

ACTIVE COMPARATOR

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.

Drug: insulin glargine

Interventions

NNC0472-0147 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.

NNC0472-0147 Part 1; NNC0472-0147 Part 2

insulin glargine DRUG

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

Insulin glargine Part 2

Placebo (NNC0472-0147) DRUG

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

Placebo Part 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Reporting Anchor & Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Single ascending dose, placebo control. Part 2: Multiple ascending dose design, active control.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: March 2, 2020
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)