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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965013
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
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.
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 : June 5, 2019
Actual Primary Completion Date : December 14, 2019
Actual Study Completion Date : December 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From 0 hours until last measurement time after trial product administration (day 1) ]
    pmol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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):

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965013


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03965013    
Other Study ID Numbers: NN1965-4456
2018-003922-98 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1221-9696 ( Registry Identifier: World Health Organization (WHO) )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs