Effect of Insulin Detemir on Blood Glucose Control in Sub... | NCT00383877

Studies
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT00383877

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 2, 2024Actual

Enrollment

263Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin detemir
insulin NPH

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

Dec 2023

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

Sep 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Oct 3, 2006

First Submission Date that Met QC Criteria

Oct 3, 2006

First Posted Date

Oct 4, 2006Estimated

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

Dec 29, 2023

Last Update Posted Date

Jan 2, 2024Actual

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 trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

263Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		after 20 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
FBG		after 20 weeks of treatment
Safety profile		during 20 weeks treatment
Proportion of subjects achieving HbA1c less than or equal to 7.0%

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
HbA1C greater than 7.5% and less than or equal to 11.0%
Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion Criteria:

Previous acute treatment with insulin for more than 7 days.
Treatment with OAD(s) which does not adhere to the approval labeling.
Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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
		Beijing			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

Intervention Browse Module

MeSH Terms

ID	Term
D000069057	Insulin Detemir
D007336	Insulin, Isophane

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided