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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: November 4, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: biphasic human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point blood glucose profiles [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: April 1998
Study Completion Date: September 1998
Primary Completion Date: September 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily
Active Comparator: B Drug: biphasic human insulin
Injected subcutaneously (under the skin) twice daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01467323

Wien, Austria, A 1080
Leipzig, Germany, 04177
Dublin, Ireland, DUBLIN 8
United Kingdom
Bolton, United Kingdom, BL1 4QS
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Helle Kastberg Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01467323     History of Changes
Other Study ID Numbers: ANA/DCD/038 
Study First Received: November 4, 2011
Last Updated: November 4, 2011
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 28, 2016