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

NCT ID: NCT02964104

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-15
• Study Completion Date: 2017-12-12

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Insulin 287 + placebo

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)

Group Type: EXPERIMENTAL

Insulin icodec

Intervention Type: DRUG

Administered once weekly subcutaneously (s.c., under the skin) for 35 days

placebo

Intervention Type: DRUG

Administered once daily subcutaneously for 35 days

Insulin degludec + placebo

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)

Group Type: ACTIVE_COMPARATOR

insulin degludec

Intervention Type: DRUG

Administered once daily subcutaneously for 35 days

placebo

Intervention Type: DRUG

Administered once weekly subcutaneously for 35 days

Interventions

Insulin icodec

Administered once weekly subcutaneously (s.c., under the skin) for 35 days

Intervention Type: DRUG

placebo

Administered once daily subcutaneously for 35 days

Intervention Type: DRUG

insulin degludec

Administered once daily subcutaneously for 35 days

Intervention Type: DRUG

placebo

Administered once weekly subcutaneously for 35 days

Intervention Type: DRUG

Other Intervention Names

insulin 287

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 34413118 (View on PubMed)

Other Identifiers

2016-000436-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1178-9795

Identifier Type: OTHER

Identifier Source: secondary_id

NN1436-4314

Identifier Type: -

Identifier Source: org_study_id