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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03965013
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 4
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Healthy Volunteers	Drug: NNC0268-0965; Drug: Placebo; Drug: insulin glargine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 5, 2019
• Actual Primary Completion Date: Dec 14, 2019
• Actual Study Completion Date: Dec 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 (healthy): NNC0268-0965 A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)	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 Comparator: Part 1 (healthy): placebo A single dose of placebo (NNC0268-0965) given s.c.	Drug: Placebo; A single dose of placebo given in Part 1
Experimental: Part 2 (type 1 diabetes): NNC0268-0965 A single dose of NNC0268-0965 given s.c.	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
Active Comparator: Part 2 (type 1 diabetes): insulin glargine A single dose of insulin glargine given s.c.	Drug: insulin glargine; Insulin glargine given at a fixed dose level of 0.5 U/kg

Outcome Measures

Primary Outcome Measures

1. Number of treatment-emergent adverse events [From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10]

   Number of events

Secondary Outcome Measures

1. 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]

   Number of episodes

2. Area under the serum NNC0268-0965 concentration-time curve after a single dose [From 0 hours until infinity after trial product administration (day 1)]

   pmol*h/L

3. Maximum observed serum NNC0268-0965 concentration after a single dose [From 0 hours until last measurement time after trial product administration (day 1)]

   pmol/L

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Neuss		Germany	41460

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03965013
• Other Study ID Numbers: NN1965-4456; 2018-003922-98; U1111-1221-9696
• First Posted: May 28, 2019
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Glargine

Study Results

No Results Posted as of Jan 14, 2021