The Effects of Short-Term Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Whether GLP-1 and GLP-1 receptor agonists will produce a sustained improvement in beta-cell function following short-term therapy is currently not known. This randomized, controlled trial is carried to assess the efficacy of short-term insulin therapy (NPH injection twice daily) compared with GLP-1 analogue (Exenatide injection twice daily) on glycemic control, remission rate, ß-cell function, and long-term glycemic control in newly diagnosed type 2 diabetic patients with moderate hyperglycemia.

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

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Exenatide; Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

1. Newly diagnosed type 2 diabetic patients.

2. Age between 30 and 70 years old.

3. HbA1C between 7 and 9% in OPD patients

4. If HbA1c >9.0% of blood glucose >300 mg/dL, intensive insulin therapy for 10-14 days

Exclusion Criteria:

1. Previous treated with anti-diabetic medication

2. Pregnant or lactation women.

3. Impaired liver function (ALT > 100 U/L)

4. Impaired renal function (Serum creatinine >2.0 mg/dL)

5. Recently suffered from MI or CVA.

6. Patients are acute intercurrent illness.

7. 2-hour C-peptide level < 2.0 ng/mL.

8. History of severe hypersensitivity to any product components.

9. History or high risk of acute pancreatitis.

10. Now use warfarin.