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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00593255
First received: January 2, 2008
Last updated: May 24, 2012
Last verified: May 2012
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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 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:
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 ] [ 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
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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 | |
| Beijing, Beijing, China, 100853 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Ma Zhaoyu, BS | Novo Nordisk A/S | |
| Study Director: | Cheng Yuwei, BS | Novo Nordisk A/S |
More Information
Additional Information:
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 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases |
Metabolic Diseases Insulin Insulin Aspart Insulin, Globin Zinc Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015