Back to resultsA Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1, Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC0268-0965
Placebo
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility 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):
- Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
- 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).
- Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- HbA1c equal to or below 8.5%.
- 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.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Arm Label
Part 1 (healthy): NNC0268-0965
Part 1 (healthy): placebo
Part 2 (type 1 diabetes): NNC0268-0965
Part 2 (type 1 diabetes): insulin glargine
Arm Description
A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)
A single dose of placebo (NNC0268-0965) given s.c.
A single dose of NNC0268-0965 given s.c.
A single dose of insulin glargine given s.c.
Outcomes
Primary Outcome Measures
Number of treatment-emergent adverse events
Number of events
Secondary Outcome Measures
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Area under the serum NNC0268-0965 concentration-time curve after a single dose
pmol*h/L
Maximum observed serum NNC0268-0965 concentration after a single dose
pmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03965013
Brief Title
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 (healthy): NNC0268-0965
Arm Type
Experimental
Arm Description
A single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)
Arm Title
Part 1 (healthy): placebo
Arm Type
Placebo Comparator
Arm Description
A single dose of placebo (NNC0268-0965) given s.c.
Arm Title
Part 2 (type 1 diabetes): NNC0268-0965
Arm Type
Experimental
Arm Description
A single dose of NNC0268-0965 given s.c.
Arm Title
Part 2 (type 1 diabetes): insulin glargine
Arm Type
Active Comparator
Arm Description
A single dose of insulin glargine given s.c.
Intervention Type
Drug
Intervention Name(s)
NNC0268-0965
Intervention Description
2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single dose of placebo given in Part 1
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Insulin glargine given at a fixed dose level of 0.5 U/kg
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events
Description
Number of events
Time Frame
From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Secondary Outcome Measure Information:
Title
Number of treatment-emergent hypoglycaemic episodes
Description
Number of episodes
Time Frame
From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Title
Area under the serum NNC0268-0965 concentration-time curve after a single dose
Description
pmol*h/L
Time Frame
From 0 hours until infinity after trial product administration (day 1)
Title
Maximum observed serum NNC0268-0965 concentration after a single dose
Description
pmol/L
Time Frame
From 0 hours until last measurement time after trial product administration (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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):
Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
Diagnosed with type 1 diabetes mellitus equal to or more than1 year prior to the day of screening.
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).
Current daily total insulin treatment between 0.2 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
HbA1c equal to or below 8.5%.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
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