Observational Study to Investigate the Efficacy and Safet... | NCT00806936

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

NCT00806936

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

4,847Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

human insulin
insulin analogue

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 10, 2008

First Submission Date that Met QC Criteria

Dec 10, 2008

First Posted Date

Dec 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,847Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: human insulin
B			Drug: insulin analogue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
human insulin	Drug	Any kind of human insulin administered at the discretion of the physician	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients achieving HbA1c below 7.0%		at 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Beijing	Beijing Municipality	100004	China

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones