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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00834262
First received: February 2, 2009
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 50
Drug: biphasic insulin aspart 70

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of all hypoglycaemic episodes [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of adverse drug reactions [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of adverse events [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of all major hypoglycaemic (daytime and nocturnal) episodes [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of major hypoglycaemic episodes related to omission of a meal after injection [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration [ Time Frame: during 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Weight (BMI) change [ Time Frame: at the end of the study after 13 weeks of treatment ] [ Designated as safety issue: Yes ]
  • HbA1c change [ Time Frame: at the end of the study after 13 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 339
Study Start Date: April 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834262

Locations
Israel
Kfar Saba, Israel, 44425
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yael Silberpfennig Novo Nordisk Israel, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00834262     History of Changes
Other Study ID Numbers: BIASP-3669
Study First Received: February 2, 2009
Last Updated: June 15, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on April 22, 2014