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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT00675493
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-09
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 942

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	For the duration of the study

Secondary Outcome Measures

Name	Time	Method
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