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Completed

NCT Number: NCT01796366

A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 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 NNC0123-0000-0338 (insulin 338) 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

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 subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) 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 12 months or more

Exclusion criteria

  • Known or suspected hypersensitivity to trial products or related products
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
  • Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol

Treatment and study plan

insulin 338 (GIPET I)

Drug

Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.

Placebo

Drug

S.c placebo administered in combination with insulin 338

insulin glargine

Drug

Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.

Primary outcomes

  1. Number of treatment emergent adverse events

    Time frame: As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit

Secondary outcomes

  1. Area under the serum insulin concentration-time curve

    Time frame: During one dosing interval (0-24 hours) at steady-state (Day 10)

  2. Area under the glucose infusion rate-time curve

    Time frame: During one dosing interval (0-24 hours) at steady state (Day 10)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 21, 2013
Registry last updated
Mar 1, 2017

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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