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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
ClinicalTrials.gov Identifier:
NCT00593255
First received: January 2, 2008
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: soluble human insulin
Drug: insulin aspart
Drug: insulin NPH
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
Study Start Date: July 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593255

Locations
China, Beijing
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ma Zhaoyu, BS Novo Nordisk
Study Director: Cheng Yuwei, BS Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00593255     History of Changes
Other Study ID Numbers: ANA-1634
Study First Received: January 2, 2008
Last Updated: May 24, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013