Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

Overall Status Completed
Start Date May 2008
Completion Date January 2009
Primary Completion Date January 2009
Study Type Observational
Primary Outcome
Measure Time Frame
Change in HbA1c from baseline For the duration of the study
Secondary Outcome
Measure Time Frame
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% after 12 weeks and 24 weeks of treatment
Change in FPG (glucose variability) after 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control) after 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections at 12 weeks and 24 weeks of treatment
Change in oral antidiabetic drug therapy after 12 weeks and 24 weeks of treatment
Change in body weight at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR) after 12 weeks and 24 weeks of treatment
Enrollment 942
Condition
Intervention

Intervention Type: Drug

Intervention Name: biphasic insulin aspart 30

Description: Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

Arm Group Label: A

Other Name: NovoMix® 30

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria:

- Subjects currently being treated with biphasic insulin aspart 30

- Subjects who were previously enrolled in this study

- Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients

- Women who are pregnant or have the intention of becoming pregnant within next 6 months

- Children below 10 years of age

Gender: All

Minimum Age: 10 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Romania

Verification Date

February 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: A

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov