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Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive 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: NCT00600366
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure
Study Start Date : March 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: biphasic insulin aspart
    Other Names:
    • BIASP
    • NovoMix 30
    • NovoLog 70/30 Mix


Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Blood glucose profiles
  2. Incidence of hypoglycaemic episodes
  3. Incidence of adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin naive diabetes
  • Current treatment with OHA, secondary failure
  • Body mass index (BMI) below 40 kg/m2
  • HbA1c over 8.5%
  • Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria:

  • History of drug or alcohol abuse
  • Receipt of the investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products
  • Severe uncontrolled hypertension
  • Any disease or condition, which the Investigator feels, would interfere with the trial

Information from the National Library of Medicine

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): NCT00600366


Locations
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Former Serbia and Montenegro
Novo Nordisk Investigational Site
Belgrade, Former Serbia and Montenegro, 11000
Novo Nordisk Investigational Site
Kragujevac, Former Serbia and Montenegro, 34000
Novo Nordisk Investigational Site
Nis, Former Serbia and Montenegro, 18000
Novo Nordisk Investigational Site
Novi Sad, Former Serbia and Montenegro, 21000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00600366    
Other Study ID Numbers: BIASP-1566
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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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
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs