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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00593255
First received: January 2, 2008
Last updated: December 21, 2016
Last verified: December 2016

January 2, 2008
December 21, 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 ClinicalTrials.gov 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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
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)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00593255
ANA-1634
No
Not Provided
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