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Completed

NCT Number: NCT01520818

Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 or Type 2 diabetes
  • Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
  • Body mass index (BMI) maximum 40.0 kg/m^2

Exclusion criteria

  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Total daily insulin dose at least 1.80 IU/kg

Treatment and study plan

biphasic insulin aspart 50

Drug

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50

biphasic insulin aspart 70

Drug

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70

biphasic human insulin 30

Drug

Administered subcutaneously (s.c., under the skin), twice a day

Primary outcomes

  1. HbA1c (glycosylated haemoglobin A1c)

Secondary outcomes

  1. Blood glucose profiles

  2. Adverse events

  3. Hypoglycaemic episodes

  4. Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)

  5. Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Jan 30, 2012
Registry last updated
Jan 4, 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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