IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01649570
First received: November 25, 2011
Last updated: July 24, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 2 | Drug: insulin aspart | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Incidence of hypoglycaemia
Secondary Outcome Measures:
- Incidence of adverse events (AEs)
- Clinical laboratory tests: Haematology and biochemistry
- Insulin antibodies
- Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)
| Enrollment: | 123 |
| Study Start Date: | March 2002 |
| Study Completion Date: | August 2003 |
| Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Insulin aspart |
Drug: insulin aspart
Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes
- Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
- HbA1c below or equal to 11.0%
- BMI (body mass index) below 30 kg/m^2
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT01649570
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649570
Locations
| Japan | |
| Tokyo, Japan, 103 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Henning Andersen | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01649570 History of Changes |
| Other Study ID Numbers: |
ANA-1472 |
| Study First Received: | November 25, 2011 |
| Last Updated: | July 24, 2012 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc |
Insulin degludec, insulin aspart drug combination Insulin Insulin Aspart Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 28, 2017