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Completed

NCT Number: NCT01520753

Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders 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

Århus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Duration of diabetes for longer than 12 months
  • Body mass index (BMI) below 35.0 kg/m^2
  • HbA1c below 11.0 %
  • Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion criteria

  • Current treatment with agents affecting glucose metabolism
  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Recurrent severe hypoglycaemia or advanced neuropathy

Treatment and study plan

biphasic insulin aspart 70

Drug

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner

biphasic insulin aspart 50

Drug

Administered subcutaneously (s.c., under the skin) at dinner

Primary outcomes

  1. Fasting serum glucose

Secondary outcomes

  1. 24-hour serum glucose profiles

  2. 24-hour insulin profiles

  3. Incidence of hypoglycaemic episodes

  4. Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blind, 4-week, Crossover Trial on Two Treatment Regimens With Biphasic Insulin Aspart 70 and 50 in Patients With Type 2 Diabetes

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
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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