Skip to main content
OpenTrials
Completed

NCT Number: NCT01467323

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Completed

Looking for future studies?

Notify Me

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, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
  • Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
  • Body mass index (BMI) below or equal to 35.0 kg/m^2
  • HbA1c below or equal to 11.0%

Exclusion criteria

  • Total daily insulin dose at least 1.4 IU/kg
  • Treatment with oral hypoglycaemic agents within the month prior to inclusion
  • Recurrent severe hypoglycaemia (as judged by the investigator)
  • Active proliferative retinopathy
  • Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
  • History of pancreatitis

Treatment and study plan

biphasic insulin aspart

Drug

Injected subcutaneously (under the skin) twice daily

biphasic human insulin

Drug

Injected subcutaneously (under the skin) twice daily

Primary outcomes

  1. HbA1c (glycosylated haemoglobin A1c)

Secondary outcomes

  1. 8-point blood glucose profiles

  2. Incidence of hypoglycaemic episodes

  3. Occurrence of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

Important dates

Study start
1998
Primary completion
1998
Study completion
1998
First posted
Nov 8, 2011
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.