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
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: 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, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014