A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes

• ClinicalTrials.gov Identifier: NCT04569994
• Recruitment Status: Recruiting
• First Posted: September 30, 2020
• Last Update Posted: April 29, 2021
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D.

The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours.

For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks.

Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers; Diabetes Mellitus, Type 1	Drug: NNC0363-0845; Drug: Placebo (NNC0363-0845); Drug: Insulin degludec	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment

Intervention Model Description

Part 1 will be a placebo-controlled trial in healthy subjects; Part 2 will be an active-controlled trial in subjects with T1D.

Part 3 of this trial, will be an open-label, two-period cross-over, randomised, single dose trial in subjects with T1D.

• 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 NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes
• Actual Study Start Date: September 30, 2020
• Estimated Primary Completion Date: July 16, 2021
• Estimated Study Completion Date: July 16, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part 1; Healthy volunteers will receive either NNC0363-0845 or placebo	Drug: NNC0363-0845; A single dose administered s.c. (subcutaneously, under the skin); Drug: Placebo (NNC0363-0845); A single dose administered s.c.
Experimental: Part 2; Participants with T1D will receive either NNC0363-0845 or insulin degludec	Drug: NNC0363-0845; A single dose administered s.c. (subcutaneously, under the skin); Drug: Insulin degludec; A single dose administered s.c.
Experimental: Part 3; Participants with T1D will receive NNC0363-0845	Drug: NNC0363-0845; A single dose administered s.c. (subcutaneously, under the skin)

Outcome Measures

Primary Outcome Measures :

1. Number of treatment-emergent adverse events (AEs) [ Time Frame: Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10 ]
   Number of events
2. Number of treatment-emergent adverse events (AEs) [ Time Frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1) ]
   Number of events

Secondary Outcome Measures :

1. Number of treatment-emergent hypoglycaemic episodes [ Time Frame: Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10 ]
   Number of episodes
2. Number of treatment-emergent hypoglycaemic episodes [ Time Frame: Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1) ]
   Number of episodes
3. Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose [ Time Frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1) ]
   pmol*h/L
4. Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose [ Time Frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1) ]
   pmol*h/L
5. Maximum observed serum NNC0363-0845 concentration after a single dose [ Time Frame: Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1) ]
   pmol/L
6. Maximum observed serum NNC0363-0845 concentration after a single dose [ Time Frame: Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1) ]
   pmol/L

Eligibility Criteria

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

Criteria

Inclusion Criteria:

Part 1 (healthy subjects):

• Male subject or female subject of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 2 and 3 (subjects with type 1 diabetes mellitus):

• Male subject or female subject of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 1 diabetes mellitus 1 year or more prior to the day of screening.
• Glycated haemoglobin (HbA1c) equal to or below 8.5%.
• Fasting C-peptide below 0.30 nmol/L.
• Considered to be generally healthy (except for type 1 diabetes mellitus and sequelae of diabetes which may only be of mild severity) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

Part 1 (healthy subjects) Part 2 and Part 3 (subjects with type 1 diabetes mellitus):

- Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (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

Contacts

Contact: Novo Nordisk; (+1) 866-867-7178; clinicaltrials@novonordisk.com

Locations

Germany

Novo Nordisk Investigational Site; Recruiting

Mainz, Germany, 55116

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency and Medical Writing Office (1452); Novo Nordisk A/S

More Information

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04569994
• Other Study ID Numbers: NN1845-4598; U1111-1244-4315 ( Other Identifier: World Health Organization (WHO) ); 2019-004658-27 ( Registry Identifier: European Medicines Agency (EudraCT) )
• First Posted: September 30, 2020
• Last Update Posted: April 29, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

• 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; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs