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Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: November 25, 2011
Last updated: July 24, 2012
Last verified: July 2012
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Incidence of hypoglycaemia

Secondary Outcome Measures:
  • Incidence of adverse events (AEs)
  • Clinical laboratory tests: Haematology and biochemistry
  • Insulin antibodies
  • Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)

Enrollment: 123
Study Start Date: March 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin aspart Drug: insulin aspart
Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks


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

Inclusion Criteria:

  • Type 2 diabetes
  • Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
  • HbA1c below or equal to 11.0%
  • BMI (body mass index) below 30 kg/m^2
  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: NCT01649570

Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Henning Andersen Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01649570     History of Changes
Other Study ID Numbers: ANA-1472
Study First Received: November 25, 2011
Last Updated: July 24, 2012

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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 17, 2017