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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
ClinicalTrials.gov Identifier:
NCT00806936
First received: December 10, 2008
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: 5314
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

  Eligibility

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

Criteria

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

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00806936     History of Changes
Other Study ID Numbers: INS-3675
Study First Received: December 10, 2008
Last Updated: July 13, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013