Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes

Completed

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

• Registration Number: NCT00715663
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1584

Inclusion Criteria

• All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.

Exclusion Criteria

Not provided

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	after 12 weeks of therapy
Change in post-prandial glucose (PPG)	after 12 weeks of therapy
Change in fasting plasma glucose (FPG)	after 12 weeks of therapy
Change in prandial glucose increment (PGI)	after 12 weeks of therapy
Incidence of hypoglycaemia and other adverse drug reaction	after 12 weeks of therapy
Patient and doctor's convenience	after 12 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice	For the duration of the study
Patient satisfaction on devices	after 12 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇩 Jakarta, Indonesia