Type 2 Diabetes. Clinical Trial
Official title:
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes
| Verified date | March 2012 |
| Source | RenJi Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 65 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Renji Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| RenJi Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | When the glucose level decreased to about 10 mmol/L | 72-96 hours | No |