Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 50

• Registration Number: NCT00755833
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Type 2 diabetes treated with biphasic human insulin with or without metformin
• Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria

• Subjects with diagnosed type 1 diabetes mellitus
• Subjects treated with short acting or intermediate acting human insulin or any insulin analogue
• Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits
• Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients
• Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	At 0, 3, 6, 9, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in insulin presentation	At 0, 3, 6, 9, 12 months
Dose and number of injections	At 0, 3, 6, 9, 12 months
Percentage of subjects achieving target HbA1c	At 0, 3, 6, 9, 12 months
Change in FPG (fasting plasma glucose)	At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)	At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)	At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events	At 0, 3, 6, 9, 12 months

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇮 Ljubljana, Slovenia