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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00806936
First received: December 10, 2008
Last updated: August 12, 2014
Last verified: August 2014

December 10, 2008
August 12, 2014
December 2008
December 2009   (final data collection date for primary outcome measure)
Percentage of patients achieving HbA1c below 7.0% [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806936 on ClinicalTrials.gov Archive Site
  • HbA1c change from baseline [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of major, minor and symptoms only hypoglycaemic episodes [ Time Frame: at 16 weeks ] [ Designated as safety issue: Yes ]
  • Comparison of scores of Insulin Treatment Appraisal Scale (ITAS) [ Time Frame: at baseline and at 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Type 2 diabetic subjects inadequately controlled with two or more oral antidiabetic drugs (OAD) and currently treated with either human insulin or insulin analogues at the discretion of physicians

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: human insulin
    Any kind of human insulin administered at the discretion of the physician
  • Drug: insulin analogue
    Any kind of insulin analogue administered at the discretion of the physician
  • A
    Intervention: Drug: human insulin
  • B
    Intervention: Drug: insulin analogue
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4847
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00806936
INS-3675
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Ren Tingting, PhD Novo Nordisk (China) Pharmaceuticals Co., Ltd
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP