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Completed

NCT Number: NCT01486940

Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

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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 3

Primary location

Novo Nordisk Investigational Site, Junín, Argentina

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 for at least 12 months
  • Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
  • BMI below or equal to 35 kg/m^2
  • HbA1c below or equal to 12%

Exclusion criteria

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
  • Subjects with known hypoglycaemic unawareness as judged by the Investigator

Treatment and study plan

insulin detemir

Drug

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

insulin aspart

Drug

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

insulin NPH

Drug

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

human soluble insulin

Drug

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

Secondary outcomes

  1. Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)

  2. 8-point blood glucose profiles

  3. Incidence of self-recorded hypoglycaemic episodes

  4. Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Dec 7, 2011
Registry last updated
Jan 27, 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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