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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:
Novo Nordisk A/S
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
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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 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:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- 2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ]
Secondary Outcome Measures:
- Percentage of subjects achieving 2-hours PPPG treatment target
- Percentage of subjects achieving HbA1c treatment target
- HbA1c
- Fasting plasma glucose
- Hypoglycaemic episodes
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593255
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593255
Locations
| 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
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
Publications:
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)
| Responsible Party: | 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: | December 21, 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin, Globin Zinc |
Insulin degludec, insulin aspart drug combination Isophane insulin, beef Insulin Insulin Aspart Insulin, Long-Acting Isophane Insulin, Human Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 22, 2017