Back to resultsA Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
Primary Purpose
Healthy Volunteers, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC0472-0147
insulin glargine
Placebo (NNC0472-0147)
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Part 1:
- Male
- Aged 18-55 years (both inclusive) at the time of signing nformed consent.
Part 2:
- Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with T2DM at least 180 days prior to the day of screening.
- Treated with any insulin for 90 days or longer prior to the day of screening.
- Low-density lipoprotein cholesterol level above 1.80 mmol L.
Exclusion Criteria:
Part 1:
- Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Part 2:
- Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
- Use of oral antidiabetic drugs (OADs) other than metformin or use of glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 90 days prior to the day of screening.
- Treatment with peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 180 days prior to the day of screening.
Sites / Locations
- Novo Nordisk Investigational Site
- 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
NNC0472-0147 Part 1
Placebo Part 1
NNC0472-0147 Part 2
Insulin glargine Part 2
Arm Description
Part 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.
Part 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.
Part 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days
Part 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.
Outcomes
Primary Outcome Measures
Part 1: Number of treatment emergent adverse events
Number of events
Part 2: Number of treatment emergent adverse events
Number of events
Secondary Outcome Measures
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Number of episodes
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Number of episodes
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Area under the serum NNC0472-0147 concentration-time curve after a single dose
pmol*h/L
Maximum observed serum NNC0472-0147 concentration after a single dose
pmol/L
Area under the serum NNC0472-0147 concentration-time curve during one dosing interval at steady state
pmol*h/L
Maximum observed serum NNC0472-0147 concentration at steady state
pmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04262661
Brief Title
A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
Official Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0472-0147 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
September 25, 2020 (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 NNC0472-0147, its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. Another goal of the study is to determine an effect of NNC0472-0147 on cholesterol. The first part of the study is conducted in healthy people, while the second part involves people with type 2 diabetes (T2DM). The study will test how NNC0472-0147 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much blood sugar is lowered. In part 1, participants will either get the new medicine NNC0472-0147 or placebo (an injection that does not contain active medicine) - which treatment is decided by chance. In part 2, participants will either get the new medicine NNC0472-0147 or insulin glargine - which treatment is decided by chance. It is the first time that NNC0472-0147 is tested in humans. Participants will get once daily injections of either NNC0472-0147 or insulin glargine for a treatment period of fourteen days. The injections will be given under the skin (subcutaneously, s.c.) of the left thigh. Participants will be in the study for about 7 weeks. There will be 15 visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health. Only women who cannot become pregnant are allowed to participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Part 1: Single ascending dose, placebo control. Part 2: Multiple ascending dose design, active control.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC0472-0147 Part 1
Arm Type
Experimental
Arm Description
Part 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.
Arm Title
Placebo Part 1
Arm Type
Placebo Comparator
Arm Description
Part 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.
Arm Title
NNC0472-0147 Part 2
Arm Type
Experimental
Arm Description
Part 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days
Arm Title
Insulin glargine Part 2
Arm Type
Active Comparator
Arm Description
Part 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.
Intervention Type
Drug
Intervention Name(s)
NNC0472-0147
Intervention Description
Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0472-0147)
Intervention Description
Part 1: A single dose of placebo, dose increased in each cohort.
Primary Outcome Measure Information:
Title
Part 1: Number of treatment emergent adverse events
Description
Number of events
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Title
Part 2: Number of treatment emergent adverse events
Description
Number of events
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Secondary Outcome Measure Information:
Title
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Title
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Title
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Title
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Title
Number of severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Title
Number of severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)
Title
Area under the serum NNC0472-0147 concentration-time curve after a single dose
Description
pmol*h/L
Time Frame
From 0 hours until infinity after a single IMP administration at day 1 (visit 2).
Title
Maximum observed serum NNC0472-0147 concentration after a single dose
Description
pmol/L
Time Frame
From 0 hours until last measurement time after a single IMP administration at day 1 (visit 2)
Title
Area under the serum NNC0472-0147 concentration-time curve during one dosing interval at steady state
Description
pmol*h/L
Time Frame
From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)
Title
Maximum observed serum NNC0472-0147 concentration at steady state
Description
pmol/L
Time Frame
From 0 to 24 hours after last multiple IMP administration at day 14 (visit 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Part 1:
Male
Aged 18-55 years (both inclusive) at the time of signing nformed consent.
Part 2:
Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (no menses for 12 months without an alternative medical cause) prior to the day of screening.
Aged 18-64 years (both inclusive) at the time of signing informed consent.
Diagnosed with T2DM at least 180 days prior to the day of screening.
Treated with any insulin for 90 days or longer prior to the day of screening.
Low-density lipoprotein cholesterol level above 1.80 mmol L.
Exclusion Criteria:
Part 1:
- Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Part 2:
Male of reproductive age who or whose partner(s) is not using highly effective contraceptive methods (highly effective contraceptive measures as required by local regulation or practice). Highly effective contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices highly effective contraception (risk of pregnancy must be lower than 1%). In addition, subjects must not donate sperm for the duration of the trial.
Use of oral antidiabetic drugs (OADs) other than metformin or use of glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 90 days prior to the day of screening.
Treatment with peptide proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 180 days prior to the day of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor & Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
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 NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
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