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Completed

NCT Number: NCT01868529

Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus

This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

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

  • Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
  • Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Body Mass Index (BMI) between 18.0 and 28.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
  • Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day

Exclusion criteria

  • Known or suspected allergy to trial product(s) or related products
  • Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
  • Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Treatment and study plan

insulin degludec

Drug

Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.

insulin glargine

Drug

Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.

Primary outcomes

  1. Area under the glucose infusion rate curve

    Time frame: 0-24 hours in steady-state

Secondary outcomes

  1. Area under the serum insulin concentration curve at steady state

    Time frame: 0-24 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Single Centre, Double-blind, Two-Period Cross-over, Multiple Dose Trial Comparing the Pharmacodynamic Response of Insulin 454 With Insulin Glargine at Steady-State Conditions in Subjects With Type 1 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2013
Registry last updated
Sep 28, 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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