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Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT00834262
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: biphasic insulin aspart 50 Drug: biphasic insulin aspart 70

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Study Type : Observational
Actual Enrollment : 339 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients
Study Start Date : April 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Group/Cohort Intervention/treatment
A Drug: biphasic insulin aspart 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30

Drug: biphasic insulin aspart 50
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Drug: biphasic insulin aspart 70
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation




Primary Outcome Measures :
  1. Number of all hypoglycaemic episodes [ Time Frame: during 13 weeks of treatment ]

Secondary Outcome Measures :
  1. Number of adverse drug reactions [ Time Frame: during 13 weeks of treatment ]
  2. Number of adverse events [ Time Frame: during 13 weeks of treatment ]
  3. Number of all major hypoglycaemic (daytime and nocturnal) episodes [ Time Frame: during 13 weeks of treatment ]
  4. Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes [ Time Frame: during 13 weeks of treatment ]
  5. Number of major hypoglycaemic episodes related to omission of a meal after injection [ Time Frame: during 13 weeks of treatment ]
  6. Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration [ Time Frame: during 13 weeks of treatment ]
  7. Weight (BMI) change [ Time Frame: at the end of the study after 13 weeks of treatment ]
  8. HbA1c change [ Time Frame: at the end of the study after 13 weeks of treatment ]
  9. Percentage of patients reaching the target of HbA1c of 7.0% or less [ Time Frame: at the end of the study after 13 weeks of treatment ]
  10. Variability in fasting blood glucose values and average (mean) fasting blood glucose level [ Time Frame: at the end of the study after 13 weeks of treatment ]
  11. Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level [ Time Frame: at the end of the study after 13 weeks of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30, NovoMix® 50 or NovoMix® 70 or combinations, will be eligible A nonrandomized sample of approximately 325 subjects with Type 2 diabetes mellitus will be enrolled.
Criteria

Inclusion Criteria:

  • Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion Criteria:

  • Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

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): NCT00834262


Locations
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Israel
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
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:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00834262     History of Changes
Other Study ID Numbers: BIASP-3669
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
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