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

Healthy Volunteers Clinical Trial

Official title:

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965013
• Other study ID #: NN1965-4456
• Secondary ID: 2018-003922-98U1
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2019
• Est. completion date: December 14, 2019

Study information

• Verified date: January 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Healthy Volunteers

Intervention

Drug:
• NNC0268-0965
2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
• Placebo
A single dose of placebo given in Part 1
• insulin glargine
Insulin glargine given at a fixed dose level of 0.5 U/kg

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of treatment-emergent hypoglycaemic episodes	Number of episodes	From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Secondary	Area under the serum NNC0268-0965 concentration-time curve after a single dose	pmol*h/L	From 0 hours until infinity after trial product administration (day 1)
Secondary	Maximum observed serum NNC0268-0965 concentration after a single dose	pmol/L	From 0 hours until last measurement time after trial product administration (day 1)