Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

This study has been completed.
Sponsor:
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
  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
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Designated as safety issue: No ]
  • Clinical laboratory tests: Haematology and biochemistry [ Designated as safety issue: No ]
  • Insulin antibodies [ Designated as safety issue: No ]
  • Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG) [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

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:
No publications provided

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
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014