Back to resultsThe Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
Primary Purpose
Type 2 Diabetes.
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The initial assessment of daily insulin dose.
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes.
Eligibility Criteria
Inclusion Criteria:
All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital.
Exclusion Criteria:
Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Newly diagnosed type 2 patients
Arm Description
The initial assessment of daily insulin dose.
Outcomes
Primary Outcome Measures
When the glucose level decreased to about 10 mmol/L
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02143440
Brief Title
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
Official Title
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newly diagnosed type 2 patients
Arm Type
Other
Arm Description
The initial assessment of daily insulin dose.
Intervention Type
Behavioral
Intervention Name(s)
The initial assessment of daily insulin dose.
Primary Outcome Measure Information:
Title
When the glucose level decreased to about 10 mmol/L
Time Frame
72-96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital.
Exclusion Criteria:
Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
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