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Completed

NCT Number: NCT00313742

The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neuss, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 Diabetes
  • Current basal-bolus insulin therapy
  • HbA1c < 10%
  • BMI < 32 kg/m2

Exclusion criteria

  • Proliferative Retinopathy / Maculopathy
  • Recurrent major hypoglycaemias
  • Impaired hepatic or renal function
  • Cardiac Problems
  • Uncontrolled hypertension

Treatment and study plan

insulin detemir

Drug

insulin glargine

Drug

insulin NPH

Drug

Primary outcomes

  1. The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise

    Time frame: following 4 weeks of treatment

Secondary outcomes

  1. Plasma glucose pre-exercise & post-exercise

  2. Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning

  3. Plasma glucose profile post-exercise

  4. Incidence of adverse events during the trial

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 12, 2006
Registry last updated
Nov 2, 2023

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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