Self-control Trial to Evaluate the Remission Rate in Newl... | NCT00494988

Studies
Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

NCT00494988

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 4, 2016Estimated

Enrollment

33Actual

Phase

Phase 4

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin aspart
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

Mar 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 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Jun 29, 2007

First Submission Date that Met QC Criteria

Jun 29, 2007

First Posted Date

Jul 2, 2007Estimated

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

Mar 3, 2016

Last Update Posted Date

Mar 4, 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 trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Measure	Description	Time Frame
Remission rate		after 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes newly diagnosed within 6-12 months
FBG: 11.1-17.0 mmol/L
Body mass index (BMI) larger than 25.0 kg/m2

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Recurrent major hypoglycaemia 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

50 Years

Standard Ages

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		100029	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
D061267	Insulin Aspart
D007336	Insulin, Isophane

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
blood glucose profiles
HbA1c