Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 17 week, randomized, single center, open-label, parallel-group study to compare glucose excursions and other efficacy and safety parameters of repaglinide thrice daily or metformin thrice daily in newly diagnosed type 2 diabetes subjects in China.

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

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Metformin; Repaglinide

Criteria

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities. (Trial- related activities are any procedure that would not have been performed during normal management of the subject.)

2. Ages between 20-90 years

3. BMI between 18.5 and 30 kg/m2

4. Newly diagnosed type 2 diabetes. Type 2 diabetes is in accordance with WHO criteria 1999

5. The history of diabetes less than 6 months

6. HbA1c <10%.

7. Only on diet and/or exercise, OAD or insulin naïve subjects

Exclusion Criteria:

1. Any history of OAD or insulin therapy preceding this trial.

2. Type 1 diabetic subjects, including LADA

3. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (adequate contraceptive measures are sterilisation, IUD, oral contraceptives or barrier methods) before and/or during the trial.

4. Impaired hepatic function (ALT > 2.5 times upper limit of local laboratories normal ranges)

5. Impaired renal function, defined as serum creatinine ≥ 1.5 mg/dl.

6. Use of systemic or inhaled glucocorticoids or other medication known to interfere with glucose metabolism.

7. Recently had acute diabetic complications

8. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

9. Recently had operation, injury, inflammation and other stress conditions.

10. Recently had cardiac disease as following: