Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cheng-Kung University Hospital |
---|---|
Information provided by: | National Cheng-Kung University Hospital |
ClinicalTrials.gov Identifier: | NCT00336310 |
The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Repaglinide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients |
Estimated Enrollment: | 50 |
Study Start Date: | July 2006 |
This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: H.Y. Ou, MD | 886-6-2353535 ext 2177 | wahoryi@mail.ncku.edu.tw |
Contact: T.J. Wu, MD | 886-6-2353535 ext 5387 | djwu@mail.ncku.edu.tw |
Taiwan | |
National Cheng-Kung University Hospital | |
Tainan, Taiwan, 704 | |
National Cheng-Kung University Hospital | |
Tainan, Taiwan, 704 |
Principal Investigator: | T-J Wu, MD | National Cheng-Kung University Hospital |
Study ID Numbers: | YSRE0001 |
Study First Received: | June 12, 2006 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00336310 |
Health Authority: | Taiwan: Department of Health, Executive Yuan |
Diabetes Mellitus Treatment Repaglinide |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Repaglinide |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |