Status:
COMPLETED
Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes
Lead Sponsor:
Chongqing Medical University
Conditions:
Diabetes
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glu...
Detailed Description
Detailed Description: OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity...
Eligibility Criteria
Inclusion
- Newly diagnosed type 2 diabetic patients.
- Drug naïve, with severe hyperglycemia (fasting plasma glucose\>11.1mmol/L or random plasma glucose \>16.7mmol/L)
- Those who age between 30 and 70 years old and can inject insulin by themselves.
Exclusion
- Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;
- Malignancy, pregnancy or lactating;
- History of ketoacidosis;
- Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine \>2 mg/dl;
- Poor blood pressure control (SBP\>180mmHg or DBP \>110mmHg);
- Definite coronary artery disease, heart failure, left ventricular hypertrophy;
- Severe anemia; acute or severe chronic diabetes complications;
- BMI\<18 kg/m2 or ≥41kg/m2;
- History of alcohol abuse or drug abuse;
- Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;
- Chronic diseases need long-term glucocorticoid treatment.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00978263
Start Date
February 1 2009
End Date
June 1 2012
Last Update
February 5 2013
Active Locations (1)
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1
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016