A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

NCT03965013 | Completed Phase 1

• 3 other identifiers: NN1965-44562018-003922-98U1111-1221-9696
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.

Conditions

Diabetes Mellitus, Type 1; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of treatment-emergent adverse events

  Number of events

  From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

Secondary Outcomes (3)

• Number of treatment-emergent hypoglycaemic episodes

  From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

• Area under the serum NNC0268-0965 concentration-time curve after a single dose

  From 0 hours until infinity after trial product administration (day 1)

• Maximum observed serum NNC0268-0965 concentration after a single dose

  From 0 hours until last measurement time after trial product administration (day 1)

Study Arms (4)

Part 1 (healthy): NNC0268-0965

EXPERIMENTAL

A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)

Drug: NNC0268-0965

Part 1 (healthy): placebo

PLACEBO COMPARATOR

A single dose of placebo (NNC0268-0965) given s.c.

Drug: Placebo

Part 2 (type 1 diabetes): NNC0268-0965

EXPERIMENTAL

A single dose of NNC0268-0965 given s.c.

Drug: NNC0268-0965

Part 2 (type 1 diabetes): insulin glargine

ACTIVE COMPARATOR

A single dose of insulin glargine given s.c.

Drug: insulin glargine

Interventions

NNC0268-0965 DRUG

2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2

Part 1 (healthy): NNC0268-0965; Part 2 (type 1 diabetes): NNC0268-0965

Placebo DRUG

A single dose of placebo given in Part 1

Part 1 (healthy): placebo

insulin glargine DRUG

Insulin glargine given at a fixed dose level of 0.5 U/kg

Part 2 (type 1 diabetes): insulin glargine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1 (healthy subjects):
• \. Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
• Part 2 (subjects with type 1 diabetes mellitus):
• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
• Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilized (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause).
• Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
• HbA1c equal to or below 8.5%.
• Fasting C-peptide below 0.30 nmol/L.

You may not qualify if:

• (Part 1 and Part 2) 1. Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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 and 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: The study consists of 2 parts each with 2 arms. Part 1 is NNC0268-0965 vs. placebo in healthy volunteers. Part 2 is NNC0268-0965 vs. insulin glargine in subjects with type 1 diabetes mellitus.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: June 5, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)