Back to resultsA Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
insulin pump
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- age: 18 ~ 85 yrs
- HbA1c: > 7.5%
- no change of anti-diabetic medication within 3 months
Exclusion Criteria:
- systemic corticosteroid administered within previous 6 months
- pregnancy
- severe liver or renal disease, heart failure
- History of cancer within 5 years
- Thyroid disease
- Anti-obesity drugs or slimming products within previous 3 months
Sites / Locations
- Konkuk University Chungju HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin pump
conventional treatment
Arm Description
insulin pump
intensification of conventional treatment
Outcomes
Primary Outcome Measures
change of HbA1c
Secondary Outcome Measures
changes of body weight
frequency of hypoglycemia
severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl
change of beta cell function
insulin secretion-sensitivity index-2
= insulinogenic index x Matsuda index
Percent of patients who reach target goal of HbA1c (<7.0%)
Full Information
NCT ID
NCT02198846
First Posted
July 22, 2014
Last Updated
July 23, 2014
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02198846
Brief Title
A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes
Official Title
A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure.
The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Insulin pump
Arm Type
Experimental
Arm Description
insulin pump
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
intensification of conventional treatment
Intervention Type
Device
Intervention Name(s)
insulin pump
Intervention Description
stop any antihyperglycemic medication and convert to insulin pump
Intervention Type
Drug
Intervention Name(s)
conventional treatment
Intervention Description
intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)
Primary Outcome Measure Information:
Title
change of HbA1c
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
changes of body weight
Time Frame
24 weeks
Title
frequency of hypoglycemia
Description
severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl
Time Frame
24 weeks
Title
change of beta cell function
Description
insulin secretion-sensitivity index-2
= insulinogenic index x Matsuda index
Time Frame
24 weeks
Title
Percent of patients who reach target goal of HbA1c (<7.0%)
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
age: 18 ~ 85 yrs
HbA1c: > 7.5%
no change of anti-diabetic medication within 3 months
Exclusion Criteria:
systemic corticosteroid administered within previous 6 months
pregnancy
severe liver or renal disease, heart failure
History of cancer within 5 years
Thyroid disease
Anti-obesity drugs or slimming products within previous 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Bong Choi, MD.PhD
Phone
+82-10-4949-9504
Email
mellitus@empal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Bong Choi, MD.PhD
Organizational Affiliation
Konkuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Chungju Hospital
City
Chungju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Bong Choi, MD.PhD
Phone
+82-10-4949-9504
Email
mellitus@empal.com
First Name & Middle Initial & Last Name & Degree
Soo Bong Choi, MD.PhD
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes
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