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

NCT00806936 | Completed

• 1 other identifier: INS-3675
• Study Type: observational
• Target: 4,847
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving HbA1c below 7.0%

  at 16 weeks

Secondary Outcomes (3)

• HbA1c change from baseline

  at 16 weeks

• Incidence of major, minor and symptoms only hypoglycaemic episodes

  at 16 weeks

• Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)

  at baseline and at 16 weeks

Study Arms (2)

A

Drug: human insulin

B

Drug: insulin analogue

Interventions

human insulin DRUG

Any kind of human insulin administered at the discretion of the physician

A

insulin analogue DRUG

Any kind of insulin analogue administered at the discretion of the physician

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

CN (1)