Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 glucose toxicity with a short period of intensive insulin therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University
• Treatments: Hypoglycemic Agents; Insulin Glargine; Metformin

Criteria

Inclusion Criteria:

1. Newly diagnosed type 2 diabetic patients.

2. Drug naïve, with severe hyperglycemia (fasting plasma glucose>11.1mmol/L or random plasma glucose >16.7mmol/L)

3. Those who age between 30 and 70 years old and can inject insulin by themselves.

Exclusion Criteria:

1. Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;

2. Malignancy, pregnancy or lactating;

3. History of ketoacidosis;

4. Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine >2 mg/dl;

5. Poor blood pressure control (SBP>180mmHg or DBP >110mmHg);

6. Definite coronary artery disease, heart failure, left ventricular hypertrophy;

7. Severe anemia; acute or severe chronic diabetes complications;

8. BMI<18 kg/m2 or ≥41kg/m2;

9. History of alcohol abuse or drug abuse;

10. Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;

11. Chronic diseases need long-term glucocorticoid treatment.