Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806936

Enrollment

4847

Registered

2008-12-11

Start date

2008-12-31

Completion date

2009-12-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGhuman insulin

Any kind of human insulin administered at the discretion of the physician

DRUGinsulin analogue

Any kind of insulin analogue administered at the discretion of the physician

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving HbA1c below 7.0%	at 16 weeks

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026