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

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: human insulin; Drug: insulin analogue

Study type: Observational

Funder types: Industry

Identifiers

NCT00806936

INS-3675

Details and patient eligibility

About

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.

Enrollment: 4,847 patients

Sex: All

Volunteers: No 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

Trial design

4,847 participants in 2 patient groups

A

Treatment:

Drug: human insulin

B

Treatment:

Drug: insulin analogue