Back to resultsA Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin icodec
IGlar U100
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
- Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
- Body mass index between 18.5 and 29.0 kg/m^2 (both inclusive)
- HbA1c less than or equal to 9.0%
Exclusion Criteria:
- History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
- Known or suspected hypersensitivity to trial products or related products
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Insulin 287 followed by insulin glargine U100
Insulin glargine U100 followed by insulin 287
Arm Description
Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks.
Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment. After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling.
Outcomes
Primary Outcome Measures
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
Measured in pmol*h/L
Secondary Outcome Measures
AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state
Measured in mg/kg
GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state
Measured in mg/(kg*min)
AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose
Measured in pmol*h/L
Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose
Measured in pmol/L
tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose
Measured in hours
Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose
Measured in pmol/L
tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose
Measured in hours
t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state
Measured in hours
CI287,trough (for insulin 287) - Serum insulin 287 trough concentration
Measured in pmol/L
AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state
Measured in pmol*h/L
Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state
Measured in pmol/L
tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state
Measured in hours
CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration
Measured in pmol/L
Number of adverse events (AEs)
Number of events
Number of hypoglycaemic episodes
Number of episodes
Change in anti-insulin 287 antibody level
Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
Change in anti-insulin 287 antibody titres
Number of dilutions
Positive cross-reactive anti-human insulin antibodies
Number of patients with/without positive cross-reactive anti-human insulin antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03723772
Brief Title
A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
Official Title
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 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 compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin 287 followed by insulin glargine U100
Arm Type
Experimental
Arm Description
Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.
After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine.
After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks.
Arm Title
Insulin glargine U100 followed by insulin 287
Arm Type
Experimental
Arm Description
Run-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised.
After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment.
After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling.
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Other Intervention Name(s)
Insulin 287
Intervention Description
Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
Intervention Type
Drug
Intervention Name(s)
IGlar U100
Intervention Description
Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
Primary Outcome Measure Information:
Title
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
Description
Measured in pmol*h/L
Time Frame
From 0 to 168 hours after trial product administration (Day 50)
Secondary Outcome Measure Information:
Title
AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Description
Measured in mg/kg
Time Frame
From 16 to 52 hours after trial product administration (Day 50)
Title
AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
Description
Measured in mg/kg
Time Frame
From 138 to 168 hours after trial product administration (Day 50)
Title
GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Description
Measured in mg/(kg*min)
Time Frame
From 16 to 52 hours after trial product administration (Day 50)
Title
GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
Description
Measured in mg/(kg*min)
Time Frame
From 138 to 168 hours after trial product administration (Day 50)
Title
AUCGIR,0-24h,SS (for insulin glargine) - Area under the glucose infusion rate-time curve at steady state
Description
Measured in mg/kg
Time Frame
From 0 to 24 hours after trial product administration (Day 14)
Title
GIRmax,0-24h, SS (for insulin glargine) - Maximum observed glucose infusion rate at steady state
Description
Measured in mg/(kg*min)
Time Frame
From 0 to 24 hours after trial product administration (Day 14)
Title
AUCI287,0-168h,FD (from insulin 287) - Area under the serum insulin 287 concentration-time curve after the first dose
Description
Measured in pmol*h/L
Time Frame
From 0 to 168 hours after trial product administration (Day 1)
Title
Cmax,I287,FD (for insulin 287) - Maximum observed serum insulin 287 concentration after the first dose
Description
Measured in pmol/L
Time Frame
From 0 to 168 hours after trial product administration (Day 1)
Title
tmax,I287,FD (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the first dose
Description
Measured in hours
Time Frame
From 0 to 168 hours after trial product administration (Day 1)
Title
Cmax,I287,SS (for insulin 287) - Maximum observed serum insulin 287 concentration after the last dose
Description
Measured in pmol/L
Time Frame
From 0 to 168 hours after trial product administration (Day 50)
Title
tmax,I287,SS (for insulin 287) - Time to maximum observed serum insulin 287 concentration after the last dose
Description
Measured in hours
Time Frame
From 0 to 168 hours after trial product administration (Day 50)
Title
t½,I287,SS (for insulin 287) - Terminal half-life for insulin 287 at steady state
Description
Measured in hours
Time Frame
Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 50)
Title
CI287,trough (for insulin 287) - Serum insulin 287 trough concentration
Description
Measured in pmol/L
Time Frame
Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)
Title
AUCIGlar,τ,SS (for insulin glargine) - Area under the serum insulin glargine concentration-time curve during one dosing interval at steady state
Description
Measured in pmol*h/L
Time Frame
From 0 to 24 hours after trial product administration (Day 14)
Title
Cmax,IGlar,SS (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state
Description
Measured in pmol/L
Time Frame
From 0 to 24 hours after trial product administration (Day 14)
Title
tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state
Description
Measured in hours
Time Frame
From 0 to 24 hours after trial product administration (Day 14)
Title
CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration
Description
Measured in pmol/L
Time Frame
Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)
Title
Number of adverse events (AEs)
Description
Number of events
Time Frame
From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Title
Number of hypoglycaemic episodes
Description
Number of episodes
Time Frame
From first trial product administration (Day 1) to end of last dosing interval (Day 57 for insulin 287, day 15 for IGlar)
Title
Change in anti-insulin 287 antibody level
Description
Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
Time Frame
From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Title
Change in anti-insulin 287 antibody titres
Description
Number of dilutions
Time Frame
From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Title
Positive cross-reactive anti-human insulin antibodies
Description
Number of patients with/without positive cross-reactive anti-human insulin antibodies
Time Frame
At the follow-up visit (Visit 25, day 106)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening
Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day
Body mass index between 18.5 and 29.0 kg/m^2 (both inclusive)
HbA1c less than or equal to 9.0%
Exclusion Criteria:
History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Known or suspected hypersensitivity to trial products or related products
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 Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week
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