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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.
 
ClinicalTrials.gov Identifier: NCT00593255
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: soluble human insulin Drug: insulin aspart Drug: insulin NPH Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving 2-hours PPPG treatment target
  2. Percentage of subjects achieving HbA1c treatment target
  3. HbA1c
  4. Fasting plasma glucose
  5. Hypoglycaemic episodes

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593255


Locations
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China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100034
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100101
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100853
China, Heilongjiang
Novo Nordisk Investigational Site
Harbin, Heilongjiang, China, 150001
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
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)

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00593255    
Other Study ID Numbers: ANA-1634
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Aspart
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs