NCT03509324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 17, 2018

Last Update Submit

April 17, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • fasting plasma glucose after insulin therapy

    10 hour

Study Arms (1)

duration of disease

OTHER

different duration of disease receive insulin LISPRO

Drug: Insulin LISPRO

Interventions

Insulin LISPRODRUG

receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved

Also known as: humalog
duration of disease

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • acute complication or severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yanbing Li, MD,PhD

    Ministry of Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endocrinology Department

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

March 1, 2015

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

CN(1)