Status:
UNKNOWN
Comparison of the Effects of Repaglinide and Metformin on Glucose Excursions
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief 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 da...
Detailed Description
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 da...
Eligibility Criteria
Inclusion
- 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.)
- Ages between 20-90 years
- BMI between 18.5 and 30 kg/m2
- Newly diagnosed type 2 diabetes. Type 2 diabetes is in accordance with WHO criteria 1999
- The history of diabetes less than 6 months
- HbA1c \<10%.
- Only on diet and/or exercise, OAD or insulin naïve subjects
Exclusion
- Any history of OAD or insulin therapy preceding this trial.
- Type 1 diabetic subjects, including LADA
- 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.
- Impaired hepatic function (ALT \> 2.5 times upper limit of local laboratories normal ranges)
- Impaired renal function, defined as serum creatinine ≥ 1.5 mg/dl.
- Use of systemic or inhaled glucocorticoids or other medication known to interfere with glucose metabolism.
- Recently had acute diabetic complications
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Recently had operation, injury, inflammation and other stress conditions.
- Recently had cardiac disease as following:
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00832481
Start Date
January 1 2009
End Date
December 1 2009
Last Update
August 25 2009
Active Locations (1)
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1
PLA General Hospital
Beijing, Beijing Municipality, China, 100000