Effectiveness of Glucose Control, β Cell Function in Resp... | NCT03509324

Studies
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes

NCT03509324

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Apr 26, 2018Actual

Enrollment

67Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin LISPRO

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

Apr 2018

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

Mar 1, 2015Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 17, 2018

First Posted Date

Apr 26, 2018Actual

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

Apr 17, 2018

Last Update Posted Date

Apr 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.

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

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
duration of disease	Other	different duration of disease receive insulin LISPRO	Drug: Insulin LISPRO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin LISPRO	Drug	receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved	duration of disease

Measure	Description	Time Frame
fasting plasma glucose after insulin therapy		10 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria: different course of type 2 diabetes with poor glycemic control

Exclusion Criteria:

acute complication or severe comorbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanbing Li, MD,PhD	Ministry of Education	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
endocrinology department of the first affiliated hospital of Sun Yat-sen University		Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061268	Insulin Lispro

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided