Clinical Trials/NCT01492166

NCT01492166

Completed

Not Applicable

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice

Novo Nordisk A/S1 site in 1 country1,935 target enrollmentNovember 2006

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsbiphasic human insulin 30

Drugsbiphasic human insulin 30

Overview

Phase: Not Applicable
Intervention: biphasic human insulin 30
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 1935
Locations: 1
Primary Endpoint: Change in fasting blood glucose (FBG)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

June 2007

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes
•Not adequately controlled on their current therapy

Exclusion Criteria

Not provided

Arms & Interventions

Novolet®

Intervention: biphasic human insulin 30

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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