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

NCT00834262 | Completed

• 1 other identifier: BIASP-3669
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of all hypoglycaemic episodes

  during 13 weeks of treatment

Secondary Outcomes (11)

• 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

Study Arms (1)

A

Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

Interventions

biphasic insulin aspart 30 DRUG

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: NovoMix® 30

A

biphasic insulin aspart 50 DRUG

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

biphasic insulin aspart 70 DRUG

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Kfar Saba, 44425, Israel

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

IL (1)