Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Treatments: Exenatide; Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. newly-diagnosed type 2 diabetic patients, drug naïve

2. age 30~70 years

3. FPG 7.0~16.7mmol/L

4. BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening

5. female patients of reproductive age should practice a reliable method of birth control throughout the study

Exclusion Criteria:

1. acute or severe chronic diabetic complications

2. Recently suffered from MI or CVA.

3. severe gastrointestinal disease

4. other severe intercurrent illness

5. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)

6. tested positive for glutamic acid decarboxylase antibody

7. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug

8. history of pancreatitis

9. Pregnant or lactation women.