A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China

Novo Nordisk A/S1 site in 1 country4,847 target enrollmentDecember 2008

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionshuman insulin insulin analogue

Drugshuman insulin insulin analogue

Overview

Phase: Not Applicable
Intervention: human insulin
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 4847
Locations: 1
Primary Endpoint: Percentage of patients achieving HbA1c below 7.0%
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 observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

December 2009

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
•The selection of the subjects will be at the discretion of the individual investigator

Exclusion Criteria

•Known or suspected allergy to trial product(s) or related products
•Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
•Subjects who previously enrolled in this study
•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
•The receipt of any investigational product within 3 months prior to this trial

Arms & Interventions

A

Intervention: human insulin

B

Intervention: insulin analogue

Outcomes

Primary Outcomes

Percentage of patients achieving HbA1c below 7.0%

Time Frame: at 16 weeks

Secondary Outcomes

HbA1c change from baseline(at 16 weeks)
Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)(at baseline and at 16 weeks)
Incidence of major, minor and symptoms only hypoglycaemic episodes(at 16 weeks)