Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice

Completed

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

• Registration Number: NCT01492166
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1935

Inclusion Criteria

• Type 2 diabetes
• Not adequately controlled on their 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
Novolet®	biphasic human insulin 30	-

Primary Outcome Measures

Name	Time	Method
Change in fasting blood glucose (FBG)
Change in 2-hour post prandial blood glucose
Change in HbA1c (glycosylated haemoglobin)
Change in prandial glucose increment (PGI)

Secondary Outcome Measures

Name	Time	Method
Frequency of minor and major hypoglycaemia
Occurrence of Adverse Drug Reactions (ADR)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇩 Jakarta, Indonesia