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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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00593255
First received: January 2, 2008
Last updated: May 24, 2012
Last verified: May 2012

January 2, 2008
May 24, 2012
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 ] [ Designated as safety issue: No ]
2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ]
Complete list of historical versions of study NCT00593255 on ClinicalTrials.gov Archive Site
  • Percentage of subjects achieving 2-hours PPPG treatment target [ Designated as safety issue: No ]
  • Percentage of subjects achieving HbA1c treatment target [ Designated as safety issue: No ]
  • HbA1c [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]
  • Percentage of subjects achieving 2-hours PPPG treatment target
  • Percentage of subjects achieving HbA1c treatment target
  • HbA1c
  • Fasting plasma glucose
  • Hypoglycaemic episodes
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
Endpoint Classification: Safety/Efficacy Study
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
Not Provided

*   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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00593255
ANA-1634
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Ma Zhaoyu, BS Novo Nordisk A/S
Study Director: Cheng Yuwei, BS Novo Nordisk A/S
Novo Nordisk A/S
May 2012

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