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.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: December 10, 2008
Last updated: August 12, 2014
Last verified: August 2014
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.

Condition Intervention
Diabetes Mellitus, Type 2
Drug: human insulin
Drug: insulin analogue

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of patients achieving HbA1c below 7.0% [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4847
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: human insulin
Any kind of human insulin administered at the discretion of the physician
B Drug: insulin analogue
Any kind of insulin analogue administered at the discretion of the physician


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00806936

China, Beijing
Beijing, Beijing, China, 100004
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Ren Tingting, PhD Novo Nordisk (China) Pharmaceuticals Co., Ltd
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00806936     History of Changes
Other Study ID Numbers: INS-3675 
Study First Received: December 10, 2008
Last Updated: August 12, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 04, 2016