Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593255
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

January 2, 2008
January 14, 2008
December 22, 2016
July 2004
April 2005   (Final data collection date for primary outcome measure)
2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00593255 on Archive Site
  • Percentage of subjects achieving 2-hours PPPG treatment target
  • Percentage of subjects achieving HbA1c treatment target
  • HbA1c
  • Fasting plasma glucose
  • Hypoglycaemic episodes
Same as current
Not Provided
Not Provided
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Drug: soluble human insulin
  • Drug: insulin aspart
  • Drug: insulin NPH
Not Provided
Gao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2005
April 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or 2 diabetes for at least 4 weeks
  • Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
  • HbA1c: 7.5-13.5%
  • Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria:

  • Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
  • History of drug abuse or alcohol dependence
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP