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NCT Number: NCT01704417

A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine

This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (IDeg) or insulin glargine (IGlar).

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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–45 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

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-27.0 kg/m^2 (both inclusive)
  • Subjects performing regular physical cardiorespiratory activity
  • Glycosylated haemoglobin (HbA1c) below or equal to 9.5 %

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
  • Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Treatment and study plan

insulin degludec

Drug

Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.

insulin glargine

Drug

Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.

Primary outcomes

  1. BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise

    Time frame: From 0 to 30 minutes

Secondary outcomes

  1. BGmean,exe, mean blood glucose concentration during exercise

    Time frame: From 0 to 30 minutes

  2. BGmean,30-180min,post-exe, mean blood glucose concentration

    Time frame: Between 30 and 180 minutes, i.e. post-exercise

  3. BGminimum,30-180min,post-exe, minimum blood glucose concentration

    Time frame: Between 30 and 180 minutes, i.e. post-exercise

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Comparing the Effect of Exercise on Blood Glucose Between Insulin Degludec and Insulin Glargine in Subjects With Type 1 Diabetes

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 11, 2012
Registry last updated
Dec 16, 2016

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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