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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

• Study Type: Observational
• Enrollment (Actual): 339

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44425
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of all hypoglycaemic episodes	during 13 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; 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
• Other Study ID Numbers: BIASP-3669