Back to resultsA Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Insulin icodec
placebo
insulin degludec
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent.
- Subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ECG and laboratory safety tests, as judged by the investigator.
- Body mass index between 20.0 and 34.9 kg/m^2 (both inclusive).
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days).
- No change in insulin treatment regimen during the last 90 days prior to screening.
- Current total daily insulin treatment between 0.3 and 1.0 (I) U/kg/day (both inclusive).
Exclusion Criteria:
- Known or suspected hypersensitivity to trial products or related products.
- Female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). Females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. Postmenopausal is defined as women aged <52 years and being amenorrheic for more than one year with serum follicle stimulating hormone (FSH level >40 IU/L or aged ≥ 52 years and being amenorrheic for less than one year and with serum FSH level > 40 IU/L or aged ≥ 52 years being amenorrheic for more than one year.
- Receipt of any investigational medicinal product within 3 months before the screening visit of this trial.
- History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator.
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days.
- Use of oral antidiabetic drugs (OADs) or GLP-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin 287 + placebo
Insulin degludec + placebo
Arm Description
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAE)
Secondary Outcome Measures
AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve
AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02964104
Brief Title
A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
Official Title
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Subjects With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 287 in subjects with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin 287 + placebo
Arm Type
Experimental
Arm Description
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Arm Title
Insulin degludec + placebo
Arm Type
Active Comparator
Arm Description
Each dose group will consist of 16 subjects randomised for once-weekly s.c. (subcutaneous, under the skin) administration of insulin 287 and once daily s.c. placebo (n=12) or once-weekly s.c. placebo and once daily s.c. insulin degludec (n=4)
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Other Intervention Name(s)
insulin 287
Intervention Description
Administered once weekly subcutaneously (s.c., under the skin) for 35 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered once daily subcutaneously for 35 days
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Administered once daily subcutaneously for 35 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered once weekly subcutaneously for 35 days
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAE)
Time Frame
From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)
Secondary Outcome Measure Information:
Title
AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve
Time Frame
During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)
Title
AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state
Time Frame
At day 30 and day 35
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, age between 18 and 64 years (both inclusive) at the time of signing informed consent.
Subject who is considered to be generally healthy (with the exception of conditions associated with diabetes mellitus), based on the medical history, physical examination, and the results of vital signs, ECG and laboratory safety tests, as judged by the investigator.
Body mass index between 20.0 and 34.9 kg/m^2 (both inclusive).
Type 2 diabetes mellitus (as diagnosed clinically) for ≥12 months (365 days).
No change in insulin treatment regimen during the last 90 days prior to screening.
Current total daily insulin treatment between 0.3 and 1.0 (I) U/kg/day (both inclusive).
Exclusion Criteria:
Known or suspected hypersensitivity to trial products or related products.
Female who is pregnant, breast-feeding, or intending to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by regulation or practice)(highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation,hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner). Females who are not postmenopausal can participate in the study if they use adequate contraceptive methods. Postmenopausal is defined as women aged <52 years and being amenorrheic for more than one year with serum follicle stimulating hormone (FSH level >40 IU/L or aged ≥ 52 years and being amenorrheic for less than one year and with serum FSH level > 40 IU/L or aged ≥ 52 years being amenorrheic for more than one year.
Receipt of any investigational medicinal product within 3 months before the screening visit of this trial.
History of deep leg vein thrombosis or repeated episodes of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the investigator.
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days.
Use of oral antidiabetic drugs (OADs) or GLP-1 receptor agonists (e.g. exenatide, liraglutide) within 3 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 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
Citations:
PubMed Identifier
34413118
Citation
Nishimura E, Pridal L, Glendorf T, Hansen BF, Hubalek F, Kjeldsen T, Kristensen NR, Lutzen A, Lyby K, Madsen P, Pedersen TA, Ribel-Madsen R, Stidsen CE, Haahr H. Molecular and pharmacological characterization of insulin icodec: a new basal insulin analog designed for once-weekly dosing. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002301. doi: 10.1136/bmjdrc-2021-002301.
Results Reference
result
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A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes
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