Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions

Launched by CHINESE PLA GENERAL HOSPITAL · Jan 29, 2009

Keywords

ClinConnect 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.

Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit (see trail population). About 60 patients with newly diagnosed (within 6 months) type 2 diabetes and both insulin and oral antidiabetic drugs (OAD) naïve will be include in this study. All s...

Gender

ALL

Eligibility 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: