Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

Completed

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

• Registration Number: NCT01536600
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33010

Inclusion Criteria

• Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIAsp 30 users	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions (ADR)
Change in post prandial glucose (PPG)
Change in fasting glucose (FG)
Difference in prandial glucose increment (PGI)
Incidence of hypoglycaemic episodes

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Seoul, Korea, Republic of