Back to resultsEffectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Insulin LISPRO
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: different course of type 2 diabetes with poor glycemic control
-
Exclusion Criteria:
- acute complication or severe comorbidities
Sites / Locations
- endocrinology department of the first affiliated hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
duration of disease
Arm Description
different duration of disease receive insulin LISPRO
Outcomes
Primary Outcome Measures
fasting plasma glucose after insulin therapy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03509324
Brief Title
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
Official Title
Effectiveness and Determinants of Glucose Control, β-cell Function in Response to Short-term Intensive Insulin Pump Therapy in Different Duration of Type 2 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
June 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
duration of disease
Arm Type
Other
Arm Description
different duration of disease receive insulin LISPRO
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Other Intervention Name(s)
humalog
Intervention Description
receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved
Primary Outcome Measure Information:
Title
fasting plasma glucose after insulin therapy
Time Frame
10 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: different course of type 2 diabetes with poor glycemic control
-
Exclusion Criteria:
acute complication or severe comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD,PhD
Organizational Affiliation
Ministry of Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
endocrinology department of the first affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
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