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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806936
• Other study ID #: INS-3675
• Status: Completed
• Phase: N/A
• First received: December 10, 2008
• Last updated: October 26, 2016
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4847
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• human insulin
Any kind of human insulin administered at the discretion of the physician
• insulin analogue
Any kind of insulin analogue administered at the discretion of the physician

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving HbA1c below 7.0%		at 16 weeks	No
Secondary	HbA1c change from baseline		at 16 weeks	No
Secondary	Incidence of major, minor and symptoms only hypoglycaemic episodes		at 16 weeks	Yes
Secondary	Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)		at baseline and at 16 weeks	No

External Links

•   Clinical Trials at Novo Nordisk