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

Completed

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

• Registration Number: NCT00806936
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4847

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	insulin analogue	-
A	human insulin	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving HbA1c below 7.0%	at 16 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Beijing, Beijing, China