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NCT Number: NCT01865292

Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
  • Specific inclusion criteria for subject with type 1 diabetes:
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Specific inclusion criteria for subject with type 2 diabetes:
  • Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
  • Treated with insulin for the past 3 months prior to screening
  • Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)

Exclusion criteria

  • Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
  • Subject with a history of or presence of cancer
  • Any condition that the Investigator and/or Sponsor feels would interfere with study
  • Specific exclusion criteria for subject with type 2 diabetes:
  • Therapy with oral antidiabetic drugs within the past 3 months prior to screening

Treatment and study plan

insulin degludec

Drug

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

insulin glargine

Drug

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Primary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: 0-24 hours after dosing

Secondary outcomes

  1. Area under the insulin degludec/insulin glargine curve

    Time frame: 0-96 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 30, 2013
Registry last updated
Oct 19, 2015

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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