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

NCT02964104 | Completed Phase 1

• 3 other identifiers: NN1436-43142016-000436-18U1111-1178-9795
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAE)

  From the first trial product administration at day 1 until completion of the post-treatment follow-up visit (day 68 - 79)

Secondary Outcomes (2)

• AUCI287,τ,SS, area under the steady-state serum insulin 287 concentration-time curve

  During one dosing interval at steady-state from 0 to 168 hours after last dose (day 29)

• AUCGIR,0-24h,SS, area under the glucose infusion rate-time curve at steady state

  At day 30 and day 35

Study Arms (2)

Insulin 287 + placebo

EXPERIMENTAL

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)

Drug: Insulin icodec; Drug: placebo

Insulin degludec + placebo

ACTIVE COMPARATOR

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)

Drug: insulin degludec; Drug: placebo

Interventions

Insulin icodec DRUG

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

Also known as: insulin 287

Insulin 287 + placebo

placebo DRUG

Administered once daily subcutaneously for 35 days

Insulin 287 + placebo

insulin degludec DRUG

Administered once daily subcutaneously for 35 days

Insulin degludec + placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• 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.

  PMID: 34413118 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin icodec; insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 15, 2016
• Study Start: November 15, 2016
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

DE (1)