Safety and Efficacy of Insulin Aspart in Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT01649570 |
Recruitment Status :
Completed
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: insulin aspart | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2002 |
Actual Primary Completion Date : | August 2003 |
Actual Study Completion Date : | August 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: Insulin aspart |
Drug: insulin aspart
Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks |
- Incidence of hypoglycaemia
- 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)

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01649570
Japan | |
Tokyo, Japan, 103 |
Study Director: | Henning Andersen | Novo Nordisk A/S |
Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01649570 |
Other Study ID Numbers: |
ANA-1472 |
First Posted: | July 25, 2012 Key Record Dates |
Last Update Posted: | July 25, 2012 |
Last Verified: | July 2012 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs |