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

NCT ID: NCT03965013

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2019-12-14

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

Study Design

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

Study Groups

Part 1 (healthy): NNC0268-0965

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

Group Type: EXPERIMENTAL

NNC0268-0965

Intervention Type: 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): placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A single dose of placebo given in Part 1

Part 2 (type 1 diabetes): NNC0268-0965

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

Group Type: EXPERIMENTAL

NNC0268-0965

Intervention Type: DRUG

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

Part 2 (type 1 diabetes): insulin glargine

A single dose of insulin glargine given s.c.

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

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

Interventions

NNC0268-0965

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

Intervention Type: DRUG

Placebo

A single dose of placebo given in Part 1

Intervention Type: DRUG

insulin glargine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Part 1 (healthy subjects):

1. Male, aged 18-55 years (both inclusive) at the time of signing informed consent.

• Part 2 (subjects with type 1 diabetes mellitus):

1. Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.

2. Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.

3. 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).

4. Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).

5. HbA1c equal to or below 8.5%.

6. Fasting C-peptide below 0.30 nmol/L.

Exclusion Criteria

• (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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 and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

2018-003922-98

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1221-9696

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1965-4456

Identifier Type: -

Identifier Source: org_study_id