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NCT Number: NCT02148861

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

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 subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent
  • Females of no childbearing potential [if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L]
  • Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)
  • Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion criteria

  • Known or suspected hypersensitivity to trial products or related products
  • Receipt of any investigational medicinal products within 3 months before screening
  • Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening

Treatment and study plan

Insulin icodec

Drug

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

Other names: insulin 287

insulin degludec

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of treatment emergent adverse events

    Time frame: From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65)

Secondary outcomes

  1. Area under the steady-state serum insulin 287 concentration-time curve

    Time frame: During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)

  2. area under the glucose infusion rate - time curve at steady-state

    Time frame: At Day 31 and day 35

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2014
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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