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Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: July 24, 2012
Last updated: February 22, 2017
Last verified: February 2017
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 50 Drug: biphasic human insulin 50 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Glycosylated haemoglobin A1c (HbA1c)

Secondary Outcome Measures:
  • Occurrence of adverse event(s)
  • Blood glucose
  • Incidence of hypoglycaemic episodes
  • Change from baseline in insulin antibodies
  • Insulin doses

Enrollment: 83
Actual Study Start Date: December 13, 2000
Study Completion Date: October 18, 2001
Primary Completion Date: October 18, 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
Experimental: BHI Drug: biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Subjects with insulin treated for at least 24 weeks
  • HbA1c maximum 11.0%
  • Body mass index (BMI) below 30.0 kg/m^2
  • Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Subjects with history of severe allergic or severe hypersensitive reactions
  • Total daily insulin dose at least 100 IU
  • Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
  Contacts and Locations
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Please refer to this study by its identifier: NCT01650129

Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01650129     History of Changes
Other Study ID Numbers: BIASP-1352
Study First Received: July 24, 2012
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 17, 2017