Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00593255 |
Recruitment Status :
Completed
First Posted : January 14, 2008
Last Update Posted : December 22, 2016
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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 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 |

- 2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ]
- Percentage of subjects achieving 2-hours PPPG treatment target
- Percentage of subjects achieving HbA1c treatment target
- HbA1c
- Fasting plasma glucose
- Hypoglycaemic episodes

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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 |
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

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
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 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
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 |
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 |