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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

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date January 3, 2020
Actual Study Start Date  ICMJE June 5, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
Official Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Healthy Volunteers
Intervention  ICMJE
  • 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
  • Drug: Placebo
    A single dose of placebo given in Part 1
  • Drug: insulin glargine
    Insulin glargine given at a fixed dose level of 0.5 U/kg
Study Arms  ICMJE
  • Experimental: Part 1 (healthy): NNC0268-0965
    A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)
    Intervention: Drug: NNC0268-0965
  • Placebo Comparator: Part 1 (healthy): placebo
    A single dose of placebo (NNC0268-0965) given s.c.
    Intervention: Drug: Placebo
  • Experimental: Part 2 (type 1 diabetes): NNC0268-0965
    A single dose of NNC0268-0965 given s.c.
    Intervention: Drug: NNC0268-0965
  • Active Comparator: Part 2 (type 1 diabetes): insulin glargine
    A single dose of insulin glargine given s.c.
    Intervention: Drug: insulin glargine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 14, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965013
Other Study ID Numbers  ICMJE NN1965-4456
2018-003922-98 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1221-9696 ( Registry Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP