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Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704378
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
Actual Study Start Date : April 18, 2001
Actual Primary Completion Date : March 14, 2003
Actual Study Completion Date : March 14, 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BIAsp Drug: biphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal


Outcome Measures
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Primary Outcome Measures :
  1. Number of Hypoglycaemic episodes
  2. Occurrence of adverse events

Secondary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)
  2. Prandial increment in blood glucose
  3. 7-point blood glucose profile

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities
  • Completed the trial BIAsp-1236

Exclusion Criteria:

  • Planned changes in use of any prescription medication that may interfere with glucose regulation
  • Known or suspected allergy to trial products or related products
  • Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
  • Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704378


Locations
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Finland
Novo Nordisk Investigational Site
Kotka, Finland, 48210
Novo Nordisk Investigational Site
Kuopio, Finland, 70210
Novo Nordisk Investigational Site
Lahti, Finland, 15850
Norway
Novo Nordisk Investigational Site
Gjøvik, Norway, NO-2819
Novo Nordisk Investigational Site
Horten, Norway, NO-3188
Novo Nordisk Investigational Site
Kirkenær, Norway, 2260
Novo Nordisk Investigational Site
Kongsvinger, Norway, 2212
Novo Nordisk Investigational Site
Notodden, Norway, NO-3675
Sweden
Novo Nordisk Investigational Site
Falun, Sweden, 791 82
Novo Nordisk Investigational Site
Helsingborg, Sweden, 254 43
Novo Nordisk Investigational Site
Motala, Sweden, 591 85
United Kingdom
Novo Nordisk Investigational Site
Derby, United Kingdom, DE7 1DY
Novo Nordisk Investigational Site
Edinburgh, United Kingdom, EH16 4SA
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2JZ
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L7 8XP
Novo Nordisk Investigational Site
Scarborough, United Kingdom, YO12 6QL
Novo Nordisk Investigational Site
Wirral, Merseyside, United Kingdom, CH63 4JY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01704378     History of Changes
Other Study ID Numbers: BIASP-1386
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
 Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs